Trial Outcomes & Findings for Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise (NCT NCT04981366)
NCT ID: NCT04981366
Last Updated: 2025-06-13
Results Overview
Fat-free mass evaluated through dual-energy x-ray absorptiometry (DEXA) and reported as percentage
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
Baseline (Pre-intervention) and 16 weeks (Post-intervention)
Results posted on
2025-06-13
Participant Flow
Recruitment started: 2021-08-01 Recruitment finished: 2023-02-26
Participant milestones
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
29
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
8
|
Reasons for withdrawal
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
8
|
|
Overall Study
Health issues unrelated to the trial
|
1
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 5.6 • n=35 Participants
|
71.8 years
STANDARD_DEVIATION 5.6 • n=35 Participants
|
71.1 years
STANDARD_DEVIATION 5.3 • n=35 Participants
|
71.7 years
STANDARD_DEVIATION 5.4 • n=105 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=35 Participants
|
27 Participants
n=35 Participants
|
27 Participants
n=35 Participants
|
81 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=35 Participants
|
8 Participants
n=35 Participants
|
8 Participants
n=35 Participants
|
24 Participants
n=105 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
35 participants
n=35 Participants
|
35 participants
n=35 Participants
|
35 participants
n=35 Participants
|
105 participants
n=105 Participants
|
|
Body mass index (kg/m²)
|
36.0 kg/m²
STANDARD_DEVIATION 4.8 • n=35 Participants
|
34.8 kg/m²
STANDARD_DEVIATION 4.5 • n=35 Participants
|
34.5 kg/m²
STANDARD_DEVIATION 4 • n=35 Participants
|
35.1 kg/m²
STANDARD_DEVIATION 4.4 • n=105 Participants
|
|
Total fat-free mass (%)
|
49.6 Percentage
STANDARD_DEVIATION 5.4 • n=35 Participants
|
50.3 Percentage
STANDARD_DEVIATION 4.8 • n=35 Participants
|
50.5 Percentage
STANDARD_DEVIATION 5.1 • n=35 Participants
|
50.2 Percentage
STANDARD_DEVIATION 5.1 • n=105 Participants
|
|
Appendicular fat-free mass (kg)
|
17.7 Kg
STANDARD_DEVIATION 4.2 • n=35 Participants
|
18.0 Kg
STANDARD_DEVIATION 3.7 • n=35 Participants
|
17.4 Kg
STANDARD_DEVIATION 3.6 • n=35 Participants
|
17.7 Kg
STANDARD_DEVIATION 3.8 • n=105 Participants
|
|
Appendicular fat-free mass to body mass index ratio
|
0.49 Kg/Kg/m^2
STANDARD_DEVIATION 0.12 • n=35 Participants
|
0.52 Kg/Kg/m^2
STANDARD_DEVIATION 0.11 • n=35 Participants
|
0.51 Kg/Kg/m^2
STANDARD_DEVIATION 0.10 • n=35 Participants
|
0.51 Kg/Kg/m^2
STANDARD_DEVIATION 0.11 • n=105 Participants
|
|
Leg fat-free mass (kg)
|
13.5 Kg
STANDARD_DEVIATION 3.2 • n=35 Participants
|
13.5 Kg
STANDARD_DEVIATION 2.7 • n=35 Participants
|
13.2 Kg
STANDARD_DEVIATION 2.7 • n=35 Participants
|
13.4 Kg
STANDARD_DEVIATION 2.9 • n=105 Participants
|
|
Diabetes (n)
|
11 Participants
n=35 Participants
|
12 Participants
n=35 Participants
|
7 Participants
n=35 Participants
|
30 Participants
n=105 Participants
|
|
Hypertension (n)
|
29 Participants
n=35 Participants
|
20 Participants
n=35 Participants
|
23 Participants
n=35 Participants
|
72 Participants
n=105 Participants
|
|
Psychiatric diseases (n)
|
6 Participants
n=35 Participants
|
12 Participants
n=35 Participants
|
5 Participants
n=35 Participants
|
23 Participants
n=105 Participants
|
|
Rheumatic diseases (n)
|
4 Participants
n=35 Participants
|
3 Participants
n=35 Participants
|
6 Participants
n=35 Participants
|
13 Participants
n=105 Participants
|
|
Dyslipidemia (n)
|
16 Participants
n=35 Participants
|
15 Participants
n=35 Participants
|
13 Participants
n=35 Participants
|
44 Participants
n=105 Participants
|
|
Osteopenia (n)
|
21 Participants
n=35 Participants
|
20 Participants
n=35 Participants
|
21 Participants
n=35 Participants
|
62 Participants
n=105 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Fat-free mass evaluated through dual-energy x-ray absorptiometry (DEXA) and reported as percentage
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Percentage of Fat-free Mass
Pre
|
49.6 percentage of fat-free mass
Standard Deviation 5.4
|
50.3 percentage of fat-free mass
Standard Deviation 4.8
|
50.5 percentage of fat-free mass
Standard Deviation 5.1
|
|
Percentage of Fat-free Mass
Post
|
52.5 percentage of fat-free mass
Standard Deviation 5.9
|
52.7 percentage of fat-free mass
Standard Deviation 4.3
|
49.3 percentage of fat-free mass
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the upper and lower limbs.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Appendicular Fat-free Mass
Pre
|
17.7 Kg
Standard Deviation 4.2
|
18.0 Kg
Standard Deviation 3.7
|
17.4 Kg
Standard Deviation 3.6
|
|
Appendicular Fat-free Mass
Post
|
18.1 Kg
Standard Deviation 3.5
|
17.6 Kg
Standard Deviation 3.5
|
16.5 Kg
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)The appendicular fat-free mass (AFFM) was assessed using dual-energy X-ray absorptiometry (DXA) and expressed in kilograms (kg). The body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters (kg/m²). The AFFM/BMI ratio was computed by dividing AFFM (kg) by BMI (kg/m²), resulting in a unitless ratio. Higher values indicate greater muscle mass relative to body size
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Appendicular Fat-free Mass to Body Mass Index Ratio
Pre
|
0.49 Kg/Kg/m^2
Standard Deviation 0.12
|
0.52 Kg/Kg/m^2
Standard Deviation 0.11
|
0.51 Kg/Kg/m^2
Standard Deviation 0.10
|
|
Appendicular Fat-free Mass to Body Mass Index Ratio
Post
|
0.54 Kg/Kg/m^2
Standard Deviation 0.11
|
0.54 Kg/Kg/m^2
Standard Deviation 0.11
|
0.48 Kg/Kg/m^2
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the lower limbs.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Leg Fat-free Mass
Pre
|
13.5 Kg
Standard Deviation 3.2
|
13.5 Kg
Standard Deviation 2.7
|
13.2 Kg
Standard Deviation 2.7
|
|
Leg Fat-free Mass
Post
|
13.8 Kg
Standard Deviation 2.6
|
13.0 Kg
Standard Deviation 2.5
|
12.5 Kg
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Fat mass was evaluated trough dual-energy x-ray absorptiometry (DEXA) and reported as percentage.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Fat-mass
Pre
|
48.6 percentage of fat mass
Standard Deviation 5.6
|
47.8 percentage of fat mass
Standard Deviation 4.9
|
47.7 percentage of fat mass
Standard Deviation 5.2
|
|
Fat-mass
Post
|
45.6 percentage of fat mass
Standard Deviation 6.0
|
45.4 percentage of fat mass
Standard Deviation 4.4
|
48.9 percentage of fat mass
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Quadriceps cross-sectional area (CSA) was assessed by computed tomography imaging
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Quadriceps Cross-sectional Area (CSA)
Pre
|
51.7 cm²
Standard Deviation 13.4
|
50.7 cm²
Standard Deviation 12.1
|
50.1 cm²
Standard Deviation 14.4
|
|
Quadriceps Cross-sectional Area (CSA)
Post
|
54.3 cm²
Standard Deviation 13.4
|
51.9 cm²
Standard Deviation 12.9
|
47.7 cm²
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Rectus femoris cross-sectional area (CSA) was assessed by B-mode ultrasound.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Rectus Femoris Cross-sectional Area (CSA)
Pre
|
3.39 cm²
Standard Deviation 1.06
|
3.23 cm²
Standard Deviation 0.96
|
3.32 cm²
Standard Deviation 1.21
|
|
Rectus Femoris Cross-sectional Area (CSA)
Post
|
3.45 cm²
Standard Deviation 1.07
|
3.27 cm²
Standard Deviation 0.95
|
3.10 cm²
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Vastus lateralis cross-sectional area (CSA) was assessed by B-mode ultrasound.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Vastus Lateralis Cross-sectional Area (CSA)
Pre
|
12.32 cm²
Standard Deviation 2.69
|
12.15 cm²
Standard Deviation 2.84
|
12.13 cm²
Standard Deviation 3.53
|
|
Vastus Lateralis Cross-sectional Area (CSA)
Post
|
12.55 cm²
Standard Deviation 2.84
|
12.45 cm²
Standard Deviation 2.77
|
11.49 cm²
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Population: This exploratory subgroup analysis included only participants who consented to undergo a muscle biopsy (n = 20 out of 105 total participants).
Muscle fiber cross-sectional area (type I) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=6 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=7 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=7 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Muscle Fiber Cross-sectional Area (fCSA)- Type I
Pre
|
2240.7 µm²
Standard Deviation 901.5
|
2725.8 µm²
Standard Deviation 1121.6
|
2669.4 µm²
Standard Deviation 806.7
|
|
Muscle Fiber Cross-sectional Area (fCSA)- Type I
Post
|
3108.6 µm²
Standard Deviation 1212.8
|
2859.4 µm²
Standard Deviation 948.67
|
2614.6 µm²
Standard Deviation 1076.4
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Population: This exploratory subgroup analysis included only participants who consented to undergo a muscle biopsy (n = 20 out of 105 total participants).
Muscle fiber cross-sectional area (type II) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=6 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=7 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=7 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Muscle Fiber Cross-sectional Area (fCSA)- Type II
Pre
|
2175.6 µm²
Standard Deviation 827.6
|
2401.4 µm²
Standard Deviation 1108.8
|
2340.8 µm²
Standard Deviation 921.2
|
|
Muscle Fiber Cross-sectional Area (fCSA)- Type II
Post
|
2775.2 µm²
Standard Deviation 964.1
|
2239.5 µm²
Standard Deviation 724.8
|
2166.1 µm²
Standard Deviation 979.8
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Bone turnover was assessed by an automated electrochemiluminescence method.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=29 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=29 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=27 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I)
Pre
|
0.34 ng/mL
Standard Deviation 0.19
|
0.38 ng/mL
Standard Deviation 0.18
|
0.35 ng/mL
Standard Deviation 0.13
|
|
Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I)
Post
|
0.38 ng/mL
Standard Deviation 0.22
|
0.46 ng/mL
Standard Deviation 0.21
|
0.35 ng/mL
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Bone turnover was assessed by an automated electrochemiluminescence method.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=29 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=29 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=27 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP)
Pre
|
53.1 ng/mL
Standard Deviation 21.2
|
61.0 ng/mL
Standard Deviation 26.9
|
56.3 ng/mL
Standard Deviation 22.8
|
|
Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP)
Post
|
66.2 ng/mL
Standard Deviation 61.0
|
66.1 ng/mL
Standard Deviation 32.2
|
56.8 ng/mL
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)bone mineral density (whole-body) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Mineral Density (Whole-body)
Pre
|
1.08 g/cm²
Standard Deviation 0.11
|
1.10 g/cm²
Standard Deviation 0.11
|
1.05 g/cm²
Standard Deviation 0.12
|
|
Bone Mineral Density (Whole-body)
Post
|
1.06 g/cm²
Standard Deviation 0.11
|
1.08 g/cm²
Standard Deviation 0.11
|
1.05 g/cm²
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)bone mineral density (femur neck) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Mineral Density (Femur Neck)
Pre
|
0.75 g/cm²
Standard Deviation 0.11
|
0.75 g/cm²
Standard Deviation 0.11
|
0.74 g/cm²
Standard Deviation 0.11
|
|
Bone Mineral Density (Femur Neck)
Post
|
0.74 g/cm²
Standard Deviation 0.12
|
0.75 g/cm²
Standard Deviation 0.12
|
0.74 g/cm²
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)bone mineral density (total hip) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Mineral Density (Total Hip)
Pre
|
0.90 g/cm²
Standard Deviation 0.13
|
0.93 g/cm²
Standard Deviation 0.11
|
0.89 g/cm²
Standard Deviation 0.13
|
|
Bone Mineral Density (Total Hip)
Post
|
0.90 g/cm²
Standard Deviation 0.13
|
0.93 g/cm²
Standard Deviation 0.12
|
0.88 g/cm²
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)bone mineral density (lumbar spine) evaluated trough dual-energy x-ray absorptiometry (DEXA)
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Mineral Density (Lumbar Spine)
Pre
|
0.98 g/cm²
Standard Deviation 0.12
|
1.01 g/cm²
Standard Deviation 0.16
|
0.96 g/cm²
Standard Deviation 0.15
|
|
Bone Mineral Density (Lumbar Spine)
Post
|
0.97 g/cm²
Standard Deviation 0.12
|
1.00 g/cm²
Standard Deviation 0.16
|
0.96 g/cm²
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Bone microarchitecture (total volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Total Volumetric Density)
Pre
|
331.9 mg HA/cm³
Standard Deviation 82.0
|
309.5 mg HA/cm³
Standard Deviation 58.9
|
324.7 mg HA/cm³
Standard Deviation 75.4
|
|
Bone Microarchitecture (Total Volumetric Density)
Post
|
340.2 mg HA/cm³
Standard Deviation 85.2
|
308.6 mg HA/cm³
Standard Deviation 66.8
|
328.9 mg HA/cm³
Standard Deviation 72.9
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Bone microarchitecture (trabecular volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Trabecular Volumetric Density)
Pre
|
147.7 mg HA/cm³
Standard Deviation 37.8
|
309.5 mg HA/cm³
Standard Deviation 58.9
|
324.7 mg HA/cm³
Standard Deviation 75.4
|
|
Bone Microarchitecture (Trabecular Volumetric Density)
Post
|
152.0 mg HA/cm³
Standard Deviation 37.9
|
308.6 mg HA/cm³
Standard Deviation 66.8
|
328.9 mg HA/cm³
Standard Deviation 72.9
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Bone microarchitecture (cortical volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Cortical Volumetric Density)
Pre
|
969.9 mg HA/cm³
Standard Deviation 59.8
|
951.0 mg HA/cm³
Standard Deviation 76.1
|
972.8 mg HA/cm³
Standard Deviation 60.3
|
|
Bone Microarchitecture (Cortical Volumetric Density)
Post
|
969.9 mg HA/cm³
Standard Deviation 62.5
|
948.7 mg HA/cm³
Standard Deviation 76.3
|
975.5 mg HA/cm³
Standard Deviation 57.5
|
SECONDARY outcome
Timeframe: 16 weeksBone microarchitecture (BV/TV) was assessed at the distal region of the radius of the non-dominant limb using high-resolution peripheral quantitative computed tomography (HR-pQCT). Specifically, trabecular bone volume fraction (BV/TV) is computed as the ratio of the trabecular bone mineral density (Tb.vBMD in mg HA/cm3) and 1200 mg HA/cm3, which is assumed to be the density of fully mineralized bone. Afterwards, the values were multiplied by 100 to reflect the percentage of trabecular bone volume fraction.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (BV/TV)
Pre
|
12.5 percentage of trabecular bone volume
Standard Deviation 3.2
|
12.9 percentage of trabecular bone volume
Standard Deviation 2.8
|
12.2 percentage of trabecular bone volume
Standard Deviation 3.0
|
|
Bone Microarchitecture (BV/TV)
Post
|
12.7 percentage of trabecular bone volume
Standard Deviation 3.5
|
12.9 percentage of trabecular bone volume
Standard Deviation 3.0
|
12.3 percentage of trabecular bone volume
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)The trabecular number (Tb.N) was analyzed using the ridge extraction technique in high-resolution peripheral quantitative computed tomography (HR-pQCT). In this approach, the trabeculae were treated as elongated structures resembling ridges. The technique involves detecting the central axis (ridge) of each trabecular element in a 3D image.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Trabecular Number - Tb. N)
Pre
|
1.86 Trabeculae per mm
Standard Deviation 0.35
|
1.96 Trabeculae per mm
Standard Deviation 0.33
|
1.90 Trabeculae per mm
Standard Deviation 0.38
|
|
Bone Microarchitecture (Trabecular Number - Tb. N)
Post
|
1.90 Trabeculae per mm
Standard Deviation 0.33
|
1.93 Trabeculae per mm
Standard Deviation 0.34
|
1.90 Trabeculae per mm
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Trabecular separation (Tb.Sp), represents the average distance between trabeculae in the trabecular bone region. It was assessed using the distance transformation method, applied to the background (void space) of the trabecular structure. The transformation method measures the distance from each voxel (3D pixel) in the void space to the nearest trabecular element, and the average of these distances is then calculated. This method enables precise quantification of trabecular spacing in high-resolution 3D images. The separation is inversely related to trabecular density, as closer trabeculae indicate a higher bone volume fraction (BV/TV) and a denser bone network. The calculation of trabecular separation can be expressed as: Tb.Sp = 1- BV/TV : Tb.N
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Trabecular Separation)
Pre
|
0.493 mm
Standard Deviation 0.127
|
0.459 mm
Standard Deviation 0.092
|
0.488 mm
Standard Deviation 0.132
|
|
Bone Microarchitecture (Trabecular Separation)
Post
|
0.474 mm
Standard Deviation 0.101
|
0.474 mm
Standard Deviation 0.106
|
0.469 mm
Standard Deviation 0.117
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Trabecular thickness (Tb.Th) represents the average thickness of trabecular bone elements. It was assessed by calculating the mean thickness of the segmented trabecular structure, using the distance transformation method applied to the trabecular bone tissue. The trabecular thickness is calculated as a ratio of the bone volume fraction (BV/TV) to trabecular number (Tb.N): Tb.Th =BV/TV : Tb.N
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Trabecular Thickness)
Pre
|
0.066 mm
Standard Deviation 0.014
|
0.066 mm
Standard Deviation 0.013
|
0.066 mm
Standard Deviation 0.012
|
|
Bone Microarchitecture (Trabecular Thickness)
Post
|
0.064 mm
Standard Deviation 0.013
|
0.068 mm
Standard Deviation 0.012
|
0.067 mm
Standard Deviation 0.011
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Cortical porosity (Ct.Po) is quantified using a density-based approach that segments bone into three compartments: compact cortex, transitional zone, and trabecular compartment. Voxels with a density below 1000 mg HA/cm³ indicate the presence of void space (pores), and porosity is estimated as the ratio of void space in each voxel. The mean of this ratio is calculated across all voxels in the compartment of interest, and the values were multiplied by 100. This method captures pores with diameters below the scanner's spatial resolution but relies on the assumption of fixed bone tissue mineral density and may be susceptible to image noise and beam hardening.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Cortical Porosity)
Pre
|
3.5 percentage
Standard Deviation 2.5
|
3.5 percentage
Standard Deviation 2.2
|
3.2 percentage
Standard Deviation 2.4
|
|
Bone Microarchitecture (Cortical Porosity)
Post
|
3.1 percentage
Standard Deviation 1.3
|
3.4 percentage
Standard Deviation 2.6
|
3.5 percentage
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Bone microarchitecture (cortical thickness) wwas assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Cortical Thickness)
Pre
|
0.958 mm
Standard Deviation 0.242
|
0.827 mm
Standard Deviation 0.201
|
0.908 mm
Standard Deviation 0.193
|
|
Bone Microarchitecture (Cortical Thickness)
Post
|
0.968 mm
Standard Deviation 0.240
|
0.826 mm
Standard Deviation 0.203
|
0.911 mm
Standard Deviation 0.203
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Bone microarchitecture (cortical pore diameter) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Cortical Pore Diameter)
Pre
|
0.168 mm
Standard Deviation 0.038
|
0.172 mm
Standard Deviation 0.043
|
0.169 mm
Standard Deviation 0.029
|
|
Bone Microarchitecture (Cortical Pore Diameter)
Post
|
0.166 mm
Standard Deviation 0.038
|
0.174 mm
Standard Deviation 0.038
|
0.171 mm
Standard Deviation 0.030
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Stiffness (kN/mm) is defined as the total reaction force of the model divided by the applied displacement. It represents the resistance of a material or structure to deformation under an applied load. A higher stiffness value indicates greater resistance to deformation, while a lower value suggests more flexibility.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Stiffness)
Pre
|
72.7 kN/mm
Standard Deviation 20
|
74.1 kN/mm
Standard Deviation 18.6
|
71.6 kN/mm
Standard Deviation 20.2
|
|
Bone Microarchitecture (Stiffness)
Post
|
73.5 kN/mm
Standard Deviation 18.9
|
75.1 kN/mm
Standard Deviation 19.6
|
69.7 kN/mm
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Estimated failure load is indirectly calculated from linear finite element (FE) models using a yield criterion. The failure load is estimated when a specified volume of bone tissue (critical volume) exceeds a critical strain threshold, at which point the model is assumed to have yielded. This approach is often based on the Pistoia criterion, which is used to predict the point of failure in the material based on its mechanical properties and deformation behavior.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Bone Microarchitecture (Estimated Failure Load)
Pre
|
3458 kN
Standard Deviation 910
|
3553 kN
Standard Deviation 888
|
3430 kN
Standard Deviation 948
|
|
Bone Microarchitecture (Estimated Failure Load)
Post
|
3503 kN
Standard Deviation 860
|
3598 kN
Standard Deviation 940
|
3347 kN
Standard Deviation 863
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Isometric muscle strength was evaluated using a handgrip dynamometer (Jamar®, Sammons Preston Rolyan, USA).
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Isometric Muscle Strength - Handgrip
Post
|
23.17 Kg
Standard Deviation 5.38
|
23.71 Kg
Standard Deviation 4.82
|
18.43 Kg
Standard Deviation 5.07
|
|
Isometric Muscle Strength - Handgrip
Pre
|
18.57 Kg
Standard Deviation 5.44
|
19.29 Kg
Standard Deviation 5.84
|
19.86 Kg
Standard Deviation 5.62
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Muscle strength was evaluated using maximal dynamic strength test \[1RM\])
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Muscle Strength - Upper Limbs
Pre
|
21.9 Kg
Standard Deviation 8.8
|
23.2 Kg
Standard Deviation 8.4
|
23.2 Kg
Standard Deviation 8.6
|
|
Muscle Strength - Upper Limbs
Post
|
26.9 Kg
Standard Deviation 10.3
|
28.1 Kg
Standard Deviation 8.7
|
19.2 Kg
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Muscle strength was evaluated using maximal dynamic strength test \[1RM\])
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Muscle Strength - Lower Limbs
Pre
|
99.9 Kg
Standard Deviation 35.6
|
99.6 Kg
Standard Deviation 35.7
|
106.9 Kg
Standard Deviation 43.0
|
|
Muscle Strength - Lower Limbs
Post
|
120.8 Kg
Standard Deviation 39.7
|
124.8 Kg
Standard Deviation 36.5
|
94.3 Kg
Standard Deviation 43.4
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Muscle function evaluated through battery of tests - Short Physical Performance Battery (SPPB). The SPPB is a standardized assessment of lower extremity function that includes three components: balance tests, gait speed over 4 meters, and the five-times sit-to-stand test. Each component is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate better physical performance. The SPPB is widely used to evaluate physical function, predict disability, and monitor health status in older adults.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Muscle Function (Short Physical Performance Battery)
Pre
|
8.9 score on a scale
Standard Deviation 2.1
|
8.2 score on a scale
Standard Deviation 2.2
|
9.3 score on a scale
Standard Deviation 1.6
|
|
Muscle Function (Short Physical Performance Battery)
Post
|
10.7 score on a scale
Standard Deviation 1.6
|
10.9 score on a scale
Standard Deviation 1.9
|
9.0 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)The 30-second sit-to-stand test is a simple measure of lower body strength and functional capacity. Participants are asked to rise from a seated position and sit back down as many times as possible within 30 seconds. The total number of complete sit-to-stand repetitions performed in the given time is recorded. This test is commonly used to assess physical fitness and mobility, particularly in older adults or individuals with health conditions.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Muscle Function (30-s Sit-to-stand Test)
Pre
|
10.3 number of repetitions
Standard Deviation 3.5
|
9.4 number of repetitions
Standard Deviation 3.2
|
10.4 number of repetitions
Standard Deviation 3.1
|
|
Muscle Function (30-s Sit-to-stand Test)
Post
|
12.8 number of repetitions
Standard Deviation 3.9
|
12.4 number of repetitions
Standard Deviation 3.5
|
10.2 number of repetitions
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)The Timed Up and Go (TUG) test is a simple and widely used assessment of mobility and balance. Participants are asked to stand up from a seated position, walk 3 meters, turn around, walk back to the chair, and sit down again, all as quickly as possible. The total time taken to complete the task is recorded. The TUG test is commonly used to evaluate functional mobility, fall risk, and the ability to perform daily activities, particularly in older adults or individuals with mobility impairments.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Muscle Function (Timed-up-and-go)
Pre
|
9.76 seconds
Standard Deviation 4.10
|
10.91 seconds
Standard Deviation 4.26
|
8.67 seconds
Standard Deviation 1.79
|
|
Muscle Function (Timed-up-and-go)
Post
|
8.49 seconds
Standard Deviation 2.97
|
9.01 seconds
Standard Deviation 4.37
|
9.38 seconds
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Muscle function evaluated through 4-m gait speed test. The 4-meter usual gait speed test measures the time it takes for a participant to walk a distance of 4 meters at their usual pace. The test is commonly used to assess walking speed, which is an important indicator of mobility, physical function, and overall health. The time taken to complete the 4-meter walk is recorded and used to evaluate the individual's functional capacity, with slower times potentially indicating mobility impairments or a higher risk of adverse health outcomes.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Muscle Function (Gait Speed)
Pre
|
0.95 m/s
Standard Deviation 0.23
|
0.90 m/s
Standard Deviation 0.25
|
0.98 m/s
Standard Deviation 0.18
|
|
Muscle Function (Gait Speed)
Post
|
1.13 m/s
Standard Deviation 0.26
|
1.13 m/s
Standard Deviation 0.27
|
0.97 m/s
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: 16 weeksCardiorespiratory fitness was evaluated by maximal oxygen uptake (VO²max) during a maximal exercise test on a treadmill
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Cardiorespiratory Fitness
Pre
|
16.0 mL/Kg/min
Standard Deviation 4.4
|
17.7 mL/Kg/min
Standard Deviation 3.2
|
17.6 mL/Kg/min
Standard Deviation 3.6
|
|
Cardiorespiratory Fitness
Post
|
19.2 mL/Kg/min
Standard Deviation 5.4
|
20 mL/Kg/min
Standard Deviation 2.6
|
17.9 mL/Kg/min
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a method used to estimate insulin resistance based on fasting plasma glucose and fasting insulin levels. It is calculated using the following formula: HOMA-IR = (fasting insulin \[µU/mL\] × fasting glucose \[mg/dL\]) / 405. Higher values of HOMA-IR indicate greater insulin resistance and are considered worse. There is no fixed theoretical maximum value, but typical reference ranges in healthy individuals are usually \<2. Values above this threshold may suggest impaired insulin sensitivity or metabolic dysfunction. The HOMA-IR is widely used in clinical and research settings as a surrogate marker for insulin resistance.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity
Pre
|
4.2 Index
Standard Deviation 0.2
|
4.3 Index
Standard Deviation 0.2
|
4.1 Index
Standard Deviation 0.1
|
|
Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity
Post
|
2.5 Index
Standard Deviation 0.2
|
3.1 Index
Standard Deviation 0.2
|
3.6 Index
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Brachial flow-mediated dilation (FMD) is a non-invasive measure of endothelial function, assessed using high-resolution B-mode ultrasound. The test evaluates the percent change in brachial artery diameter in response to increased blood flow (reactive hyperemia) following 3 minutes of cuff occlusion, on the forearm. An increase in arterial diameter after cuff release indicates vasodilation mediated by nitric oxide. Higher FMD values reflect better endothelial function, whereas lower values are associated with cardiovascular risk and impaired vascular health.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Brachial Flow-mediated Dilation (FMD)
Pre
|
4.6 percentage of flow mediated dilatation
Standard Deviation 0.5
|
4.8 percentage of flow mediated dilatation
Standard Deviation 0.5
|
5 percentage of flow mediated dilatation
Standard Deviation 0.6
|
|
Brachial Flow-mediated Dilation (FMD)
Post
|
7.8 percentage of flow mediated dilatation
Standard Deviation 0.6
|
6.3 percentage of flow mediated dilatation
Standard Deviation 0.6
|
2.6 percentage of flow mediated dilatation
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Lipid Profile (HDL)
Pre
|
52.1 mg/dL
Standard Deviation 0.9
|
52.8 mg/dL
Standard Deviation 0.9
|
52.8 mg/dL
Standard Deviation 0.9
|
|
Lipid Profile (HDL)
Post
|
51.4 mg/dL
Standard Deviation 0.9
|
51.5 mg/dL
Standard Deviation 0.9
|
51.7 mg/dL
Standard Deviation 0.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Lipid Profile (LDL)
Pre
|
116.1 mg/dL
Standard Deviation 3.4
|
115.5 mg/dL
Standard Deviation 3.5
|
116.8 mg/dL
Standard Deviation 3.5
|
|
Lipid Profile (LDL)
Post
|
111.1 mg/dL
Standard Deviation 3.8
|
111.4 mg/dL
Standard Deviation 3.6
|
112.3 mg/dL
Standard Deviation 3.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Lipid Profile (VLDL)
Post
|
22.8 mg/dL
Standard Deviation 0.8
|
22.8 mg/dL
Standard Deviation 0.8
|
23.9 mg/dL
Standard Deviation 0.8
|
|
Lipid Profile (VLDL)
Pre
|
25.2 mg/dL
Standard Deviation 0.7
|
25.4 mg/dL
Standard Deviation 0.7
|
25.1 mg/dL
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Lipid Profile (Triglycerides)
Pre
|
140.4 mg/dL
Standard Deviation 4.9
|
141.1 mg/dL
Standard Deviation 5
|
138.8 mg/dL
Standard Deviation 5.1
|
|
Lipid Profile (Triglycerides)
Post
|
119.0 mg/dL
Standard Deviation 5.3
|
122.5 mg/dL
Standard Deviation 5.3
|
130.8 mg/dL
Standard Deviation 5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
Relative telomere length was measured using quantitative polymerase chain reaction (qPCR), which determines the ratio of telomeric repeat copy number (T) to a single-copy gene number (S) in a given sample. This T/S ratio is a unitless index that reflects the average telomere length relative to the reference gene. Higher T/S ratios indicate longer telomeres, while lower values indicate shorter telomeres. Although the T/S ratio does not provide absolute telomere length in base pairs, it is a widely used, validated method to assess relative telomere length in epidemiological and clinical research.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=27 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Telomere Length
Pre
|
0.98 Ratio
Standard Deviation 0.05
|
0.97 Ratio
Standard Deviation 0.05
|
0.99 Ratio
Standard Deviation 0.05
|
|
Telomere Length
Post
|
0.99 Ratio
Standard Deviation 0.06
|
0.99 Ratio
Standard Deviation 0.04
|
0.99 Ratio
Standard Deviation 0.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
Superoxide dismutase (SOD) activity was measured using an enzyme-linked immunosorbent assay (ELISA), following the manufacturer's instructions. The assay is based on the competitive binding of SOD present in the sample and a SOD standard to a monoclonal antibody coated on a microplate.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=27 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Oxidative Stress - Superoxide Dismutase
Pre
|
22.6 percentage inhibition per 2 µL of samp
Standard Deviation 5.8
|
21.5 percentage inhibition per 2 µL of samp
Standard Deviation 4.0
|
21.5 percentage inhibition per 2 µL of samp
Standard Deviation 5.5
|
|
Oxidative Stress - Superoxide Dismutase
Post
|
23.2 percentage inhibition per 2 µL of samp
Standard Deviation 4.9
|
23.3 percentage inhibition per 2 µL of samp
Standard Deviation 4.1
|
22.6 percentage inhibition per 2 µL of samp
Standard Deviation 4.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
Catalase activity was assessed using an enzyme-linked immunosorbent assay (ELISA), according to the manufacturer's protocol. The assay quantifies catalase based on the competition between the sample catalase and a catalase standard for binding to specific antibodies coated on the microplate. The detection is achieved through a colorimetric reaction measured at a specific wavelength.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=27 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Oxidative Stress - Catalase Activity
Pre
|
6.2 U/mL
Standard Deviation 2.3
|
6.6 U/mL
Standard Deviation 0.8
|
5.8 U/mL
Standard Deviation 2.7
|
|
Oxidative Stress - Catalase Activity
Post
|
6.0 U/mL
Standard Deviation 2.6
|
6.8 U/mL
Standard Deviation 0.8
|
5.7 U/mL
Standard Deviation 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
Glutathione peroxidase activity was measured using a colorimetric assay according to the manufacturer's instructions. The method is based on the enzyme-catalyzed reduction of hydrogen peroxide by reduced glutathione (GSH), forming oxidized glutathione (GSSG). In the presence of glutathione reductase and NADPH, GSSG is converted back to GSH with concomitant oxidation of NADPH to NADP⁺.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=27 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Oxidative Stress - Glutathione Peroxidase
Pre
|
404.2 µmol GSH/min/mL
Standard Deviation 52.8
|
406.5 µmol GSH/min/mL
Standard Deviation 49.5
|
401.2 µmol GSH/min/mL
Standard Deviation 40.7
|
|
Oxidative Stress - Glutathione Peroxidase
Post
|
416.3 µmol GSH/min/mL
Standard Deviation 45.7
|
412.5 µmol GSH/min/mL
Standard Deviation 47.9
|
396.1 µmol GSH/min/mL
Standard Deviation 39.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
Oxidative stress markers (SOD, CAT, glutathione, GPx, GST and TBARS) were assessed through ELISA assay.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=27 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Oxidative Stress - Glutathione Reductase
Pre
|
48.7 µmol NADPH/min/mL
Standard Deviation 3.2
|
48.0 µmol NADPH/min/mL
Standard Deviation 3.0
|
48.4 µmol NADPH/min/mL
Standard Deviation 2.4
|
|
Oxidative Stress - Glutathione Reductase
Post
|
49.6 µmol NADPH/min/mL
Standard Deviation 4.2
|
47.3 µmol NADPH/min/mL
Standard Deviation 4.8
|
49.1 µmol NADPH/min/mL
Standard Deviation 2.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
Glutathione S-transferase (GST) activity was assessed using a colorimetric assay based on the conjugation of the substrate 1-chloro-2,4-dinitrobenzene (CDNB) with reduced glutathione (GSH). The reaction results in a yellow product that is quantified by measuring the absorbance at 340 nm.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=27 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Oxidative Stress - Glutathione S-transferases
Pre
|
17.4 pmol GSH conjugates/min/mL
Standard Deviation 6.5
|
18.7 pmol GSH conjugates/min/mL
Standard Deviation 11.6
|
18.3 pmol GSH conjugates/min/mL
Standard Deviation 9.3
|
|
Oxidative Stress - Glutathione S-transferases
Post
|
21.3 pmol GSH conjugates/min/mL
Standard Deviation 7.1
|
19.8 pmol GSH conjugates/min/mL
Standard Deviation 9.6
|
18.6 pmol GSH conjugates/min/mL
Standard Deviation 9.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Population: This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.
Thiobarbituric Acid Reactive Substances (TBARS): Lipid peroxidation was assessed by measuring thiobarbituric acid reactive substances (TBARS), following the manufacturer's instructions. This colorimetric assay detects malondialdehyde (MDA), a byproduct of lipid peroxidation, which reacts with thiobarbituric acid to form a colored complex measurable at 532-535 nm. Results are expressed as micromoles of MDA equivalents per liter (µmol/L), with higher values indicating greater oxidative stress.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=27 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=27 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Oxidative Stress - Thiobarbituric Acid Reactive Substances
Pre
|
2.05 µmol/L
Standard Deviation 0.93
|
2.06 µmol/L
Standard Deviation 1.20
|
1.94 µmol/L
Standard Deviation 0.52
|
|
Oxidative Stress - Thiobarbituric Acid Reactive Substances
Post
|
1.97 µmol/L
Standard Deviation 0.84
|
2.15 µmol/L
Standard Deviation 1.21
|
2.25 µmol/L
Standard Deviation 0.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Inflammatory Profile - IL1β
Pre
|
1.45 pg/mL
Standard Deviation 0.37
|
1.33 pg/mL
Standard Deviation 0.37
|
1.01 pg/mL
Standard Deviation 0.38
|
|
Inflammatory Profile - IL1β
Post
|
1.46 pg/mL
Standard Deviation 0.37
|
0.88 pg/mL
Standard Deviation 0.37
|
1.22 pg/mL
Standard Deviation 0.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Inflammatory Profile - IL-10
Pre
|
3.75 pg/mL
Standard Deviation 0.75
|
4.46 pg/mL
Standard Deviation 0.76
|
3.56 pg/mL
Standard Deviation 0.77
|
|
Inflammatory Profile - IL-10
Post
|
3.78 pg/mL
Standard Deviation 0.75
|
2.47 pg/mL
Standard Deviation 0.76
|
3.96 pg/mL
Standard Deviation 0.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Inflammatory Profile - IL-6
Pre
|
3.30 pg/mL
Standard Deviation 0.46
|
2.99 pg/mL
Standard Deviation 0.46
|
2.92 pg/mL
Standard Deviation 0.47
|
|
Inflammatory Profile - IL-6
Post
|
2.49 pg/mL
Standard Deviation 0.46
|
2.49 pg/mL
Standard Deviation 0.46
|
3.25 pg/mL
Standard Deviation 0.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Inflammatory Profile - TNF-α
Pre
|
20.1 pg/mL
Standard Deviation 1.2
|
19.6 pg/mL
Standard Deviation 1.2
|
19.4 pg/mL
Standard Deviation 1.2
|
|
Inflammatory Profile - TNF-α
Post
|
14.7 pg/mL
Standard Deviation 1.2
|
15.5 pg/mL
Standard Deviation 1.2
|
20.1 pg/mL
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Inflammatory profile (i.e.; C-Reactive Protein ) was quantified via an immunoturbidimetric assay.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Inflammatory Profile - C-Reactive Protein
Pre
|
5.76 pg/mL
Standard Deviation 0.79
|
5.19 pg/mL
Standard Deviation 0.81
|
6.01 pg/mL
Standard Deviation 0.83
|
|
Inflammatory Profile - C-Reactive Protein
Post
|
4.25 pg/mL
Standard Deviation 0.87
|
5.74 pg/mL
Standard Deviation 0.86
|
5.54 pg/mL
Standard Deviation 0.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)The area under the curve (AUC) of blood glucose was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the blood glucose response over the 2-hour period following glucose ingestion.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Area Under the Curve (AUC) of Blood Glucose
Pre
|
683.54 mg·min/dL
Interval 617.38 to 749.7
|
641.73 mg·min/dL
Interval 574.51 to 708.94
|
648.99 mg·min/dL
Interval 581.77 to 716.2
|
|
Area Under the Curve (AUC) of Blood Glucose
Post
|
599.51 mg·min/dL
Interval 533.35 to 665.66
|
622.22 mg·min/dL
Interval 555.0 to 689.43
|
638.20 mg·min/dL
Interval 570.98 to 705.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)The area under the curve (AUC) of insulin was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the insulin response over the 2-hour period following glucose ingestion.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Area Under the Curve (AUC) of Insulin
Pre
|
442.08 μU·min/mL
Interval 355.59 to 528.58
|
417.23 μU·min/mL
Interval 329.35 to 505.11
|
432.69 μU·min/mL
Interval 344.81 to 520.57
|
|
Area Under the Curve (AUC) of Insulin
Post
|
259.90 μU·min/mL
Interval 173.4 to 346.39
|
310.21 μU·min/mL
Interval 222.34 to 398.09
|
403.40 μU·min/mL
Interval 315.52 to 491.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Anxiety was assessed using the Geriatric Anxiety Inventory (GAI), a 20-item self-report questionnaire designed to measure anxiety symptoms in older adults. The total score ranges from 0 to 20, with higher scores reflecting more severe anxiety symptoms.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Anxiety
Pre
|
6.8 score on a scale
Standard Deviation 5.0
|
6.6 score on a scale
Standard Deviation 4.8
|
4.4 score on a scale
Standard Deviation 3.8
|
|
Anxiety
Post
|
4.6 score on a scale
Standard Deviation 5.1
|
5.5 score on a scale
Standard Deviation 5.3
|
4.0 score on a scale
Standard Deviation 4.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Depression was assessed using the Geriatric Depression Scale (GDS-15), a 15-item self-report questionnaire designed to measure depressive symptoms in older adults. The total score ranges from 0 to 15, with higher scores indicating more severe depression.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Depression
Pre
|
4.1 score on a scale
Standard Deviation 2.9
|
4.8 score on a scale
Standard Deviation 3.4
|
2.8 score on a scale
Standard Deviation 4.4
|
|
Depression
Post
|
2.6 score on a scale
Standard Deviation 2.8
|
2.6 score on a scale
Standard Deviation 2.8
|
2.5 score on a scale
Standard Deviation 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Health-related Quality of Life - Physical Component
Pre
|
61.2 score on a scale
Standard Deviation 24.3
|
63.9 score on a scale
Standard Deviation 22.1
|
71.8 score on a scale
Standard Deviation 19.7
|
|
Health-related Quality of Life - Physical Component
Post
|
77.2 score on a scale
Standard Deviation 19.8
|
77.2 score on a scale
Standard Deviation 19.5
|
75.6 score on a scale
Standard Deviation 18.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Health-related Quality of Life - Mental Component
Pre
|
59.3 score on a scale
Standard Deviation 22.4
|
58.9 score on a scale
Standard Deviation 23.3
|
63.0 score on a scale
Standard Deviation 19.0
|
|
Health-related Quality of Life - Mental Component
Post
|
74.8 score on a scale
Standard Deviation 17.3
|
81.5 score on a scale
Standard Deviation 13.4
|
64.5 score on a scale
Standard Deviation 21.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Pre-intervention) and 16 weeks (Post-intervention)Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire that evaluates various aspects of sleep quality. The PSQI is scored by summing the scores of seven components, each ranging from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Outcome measures
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 Participants
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 Participants
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Sleep Quality
Pre
|
5.9 score on a scale
Standard Deviation 3.2
|
7.2 score on a scale
Standard Deviation 3.6
|
5.6 score on a scale
Standard Deviation 3.0
|
|
Sleep Quality
Post
|
4.6 score on a scale
Standard Deviation 3.1
|
3.6 score on a scale
Standard Deviation 2.1
|
5.0 score on a scale
Standard Deviation 3.7
|
Adverse Events
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Control Group (CTRL)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 participants at risk
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 participants at risk
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 participants at risk
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Cardiac disorders
Third-degree atrioventricular block
|
2.9%
1/35 • Number of events 1 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/35 • 16 weeks
|
2.9%
1/35 • Number of events 1 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
Other adverse events
| Measure |
Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)
n=35 participants at risk
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.
Protein supplement: 40g of whey protein in the breakfast;
|
Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)
n=35 participants at risk
Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.
isocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;
|
Control Group (CTRL)
n=35 participants at risk
Patients allocated to this arm did not receive any intervention.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Articular pain
|
2.9%
1/35 • Number of events 1 • 16 weeks
|
2.9%
1/35 • Number of events 1 • 16 weeks
|
2.9%
1/35 • Number of events 1 • 16 weeks
|
|
General disorders
Fell during exercise training
|
2.9%
1/35 • Number of events 1 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
0.00%
0/35 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Transitory pain after muscle biopsies
|
100.0%
6/6 • Number of events 6 • 16 weeks
|
85.7%
6/7 • Number of events 6 • 16 weeks
|
85.7%
6/7 • Number of events 6 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Bruising after muscle biopsies
|
0.00%
0/6 • 16 weeks
|
14.3%
1/7 • Number of events 1 • 16 weeks
|
14.3%
1/7 • Number of events 1 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place