Trial Outcomes & Findings for Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity (NCT NCT02945410)
NCT ID: NCT02945410
Last Updated: 2019-12-19
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline and day 6
Results posted on
2019-12-19
Participant Flow
Participants Excluded prior to assignment: n = 4 did not meet inclusion criteria on preliminary questionnaires (n = 1 did not met the age requirements (reported a false age) n = 1 reported hyperthyroidism n = 2 reported insufficient levels of physical activity) n = 1 declined to participate in the study after enrolling
Participant milestones
| Measure |
(1) CRHP (2) EB (3) CRNP
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) CRHP (2) CRNP (3) EB
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) CRNP (2) EB (3) CRHP
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) CRNP (2) CRHP (3) EB
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) EB (2) CRHP (3) CRNP
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) EB (2) CRNP (3) CRHP
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
|---|---|---|---|---|---|---|
|
Intervention 1 (5 Days)
STARTED
|
3
|
4
|
2
|
3
|
2
|
1
|
|
Intervention 1 (5 Days)
COMPLETED
|
2
|
1
|
2
|
3
|
2
|
0
|
|
Intervention 1 (5 Days)
NOT COMPLETED
|
1
|
3
|
0
|
0
|
0
|
1
|
|
Washout 1 (14 Days)
STARTED
|
2
|
1
|
2
|
3
|
2
|
0
|
|
Washout 1 (14 Days)
COMPLETED
|
2
|
1
|
0
|
3
|
1
|
0
|
|
Washout 1 (14 Days)
NOT COMPLETED
|
0
|
0
|
2
|
0
|
1
|
0
|
|
Intervention 2 (5 Days)
STARTED
|
2
|
1
|
0
|
3
|
1
|
0
|
|
Intervention 2 (5 Days)
COMPLETED
|
2
|
1
|
0
|
3
|
1
|
0
|
|
Intervention 2 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 2 (14 Days)
STARTED
|
2
|
1
|
0
|
3
|
1
|
0
|
|
Washout 2 (14 Days)
COMPLETED
|
2
|
1
|
0
|
3
|
1
|
0
|
|
Washout 2 (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention 3 (5 Days)
STARTED
|
2
|
1
|
0
|
3
|
1
|
0
|
|
Intervention 3 (5 Days)
COMPLETED
|
2
|
1
|
0
|
3
|
1
|
0
|
|
Intervention 3 (5 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
(1) CRHP (2) EB (3) CRNP
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) CRHP (2) CRNP (3) EB
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) CRNP (2) EB (3) CRHP
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) CRNP (2) CRHP (3) EB
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) EB (2) CRHP (3) CRNP
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) EB (2) CRNP (3) CRHP
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
|---|---|---|---|---|---|---|
|
Intervention 1 (5 Days)
Withdrawal by Subject
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Intervention 1 (5 Days)
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Washout 1 (14 Days)
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
(1) CRHP (2) EB (3) CRNP
n=3 Participants
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) CRHP (2) CRNP (3) EB
n=4 Participants
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) CRNP (2) EB (3) CRHP
n=2 Participants
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) CRNP (2) CRHP (3) EB
n=3 Participants
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) EB (2) CRHP (3) CRNP
n=2 Participants
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
(1) EB (2) CRNP (3) CRHP
n=1 Participants
In the Energy Balance Intervention, participants will consume 55 kcal/kg FFM/day and 1.7 g protein/kg BW/day.
In the Caloric Restriction and Normal Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
In the Caloric Restriction and High Protein Intervention, participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
In all Interventions, participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day. Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms. Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
15 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=15 Participants
|
|
Age, Continuous
|
21.3 Years
STANDARD_DEVIATION 3.2 • n=3 Participants
|
19.5 Years
STANDARD_DEVIATION 0.6 • n=4 Participants
|
21 Years
STANDARD_DEVIATION 0 • n=2 Participants
|
25.3 Years
STANDARD_DEVIATION 3.8 • n=3 Participants
|
27 Years
STANDARD_DEVIATION 1.4 • n=2 Participants
|
21 Years
STANDARD_DEVIATION 0 • n=1 Participants
|
22.3 Years
STANDARD_DEVIATION 3.4 • n=15 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
15 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
4 participants
n=4 Participants
|
2 participants
n=2 Participants
|
3 participants
n=3 Participants
|
2 participants
n=2 Participants
|
1 participants
n=1 Participants
|
15 participants
n=15 Participants
|
|
Percentage Body Fat
|
17.9 % body fat
STANDARD_DEVIATION 5.2 • n=3 Participants
|
13.4 % body fat
STANDARD_DEVIATION 4.4 • n=4 Participants
|
12 % body fat
STANDARD_DEVIATION 0.1 • n=2 Participants
|
18 % body fat
STANDARD_DEVIATION 1.7 • n=3 Participants
|
19.2 % body fat
STANDARD_DEVIATION 1.8 • n=2 Participants
|
15 % body fat
STANDARD_DEVIATION 0 • n=1 Participants
|
15.9 % body fat
STANDARD_DEVIATION 4.0 • n=15 Participants
|
|
Aerobic Fitness (VO2max)
|
43.4 mL/kg/min
STANDARD_DEVIATION 2.1 • n=3 Participants
|
46.7 mL/kg/min
STANDARD_DEVIATION 5.2 • n=4 Participants
|
47.1 mL/kg/min
STANDARD_DEVIATION 6.5 • n=2 Participants
|
41.0 mL/kg/min
STANDARD_DEVIATION 10.4 • n=3 Participants
|
41.6 mL/kg/min
STANDARD_DEVIATION 5.0 • n=2 Participants
|
42.3 mL/kg/min
STANDARD_DEVIATION 0 • n=1 Participants
|
43.6 mL/kg/min
STANDARD_DEVIATION 5.7 • n=15 Participants
|
PRIMARY outcome
Timeframe: Baseline and day 6Outcome measures
| Measure |
Caloric Restriction and High Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Caloric Restriction and Normal Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Energy Balance
n=7 Participants
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
|---|---|---|---|
|
Change in Resting Metabolic Rate
|
-63.4 kcal change
Standard Error 58.2
|
-77.6 kcal change
Standard Error 100.1
|
-47.4 kcal change
Standard Error 41.7
|
PRIMARY outcome
Timeframe: Baseline and day 6Population: All participants completing each condition.
Outcome measures
| Measure |
Caloric Restriction and High Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Caloric Restriction and Normal Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Energy Balance
n=7 Participants
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
|---|---|---|---|
|
Change in Circulating IGF-1
|
-2.3195714 mol/L change
Standard Error 1.144509
|
-0.2107857 mol/L change
Standard Error 2.369683
|
-1.1142857 mol/L change
Standard Error 1.628160
|
PRIMARY outcome
Timeframe: Baseline and day 6Population: Participants who completed all conditions.
Outcome measures
| Measure |
Caloric Restriction and High Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Caloric Restriction and Normal Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Energy Balance
n=7 Participants
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
|---|---|---|---|
|
Change in Marker of Bone Formation (P1NP)
|
3.73 % change
Standard Error 16.82
|
4.80 % change
Standard Error 19.78
|
-3.24 % change
Standard Error 8.95
|
PRIMARY outcome
Timeframe: Baseline and day 6Outcome measures
| Measure |
Caloric Restriction and High Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Caloric Restriction and Normal Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Energy Balance
n=7 Participants
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
|---|---|---|---|
|
Change in Marker of Bone Resorption (CTx)
|
0.24 % change
Standard Error 5.56
|
6.93 % change
Standard Error 16.51
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-8.34 % change
Standard Error 10.41
|
SECONDARY outcome
Timeframe: Baseline and day 6Outcome measures
| Measure |
Caloric Restriction and High Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Caloric Restriction and Normal Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Energy Balance
n=7 Participants
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
|---|---|---|---|
|
Change in Body Weight
|
-2.3 kg
Standard Error 0.5
|
-2.1 kg
Standard Error 0.3
|
-0.0 kg
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and day 6Population: Due to equipment errors, n = 5 participants had complete body composition data for all conditions.
Outcome measures
| Measure |
Caloric Restriction and High Protein
n=5 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Caloric Restriction and Normal Protein
n=5 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Energy Balance
n=5 Participants
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
|---|---|---|---|
|
Change in Body Fat Percentage
|
-0.94 % change
Standard Error 0.23
|
-0.23 % change
Standard Error 0.41
|
-0.08 % change
Standard Error 0.53
|
SECONDARY outcome
Timeframe: Baseline and day 6Population: n = 1 participants had data missing from post-testing in one condition due to equipment failure so their data for the other conditions was removed
Analyzed in L/min rather than mL/kg/min to remove influence of weight loss.
Outcome measures
| Measure |
Caloric Restriction and High Protein
n=6 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Caloric Restriction and Normal Protein
n=6 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Energy Balance
n=6 Participants
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
|---|---|---|---|
|
Change in Aerobic Fitness (VO2peak)
|
0.25 L/min change
Standard Error 0.08
|
0.01 L/min change
Standard Error 0.06
|
0.01 L/min change
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Baseline and day 6Perceived hunger will be assessed using 0-100 visual analog scales. In this case, 100 means maximum hunger while 0 means minimal hunger.
Outcome measures
| Measure |
Caloric Restriction and High Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Caloric Restriction and Normal Protein
n=7 Participants
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Energy Balance
n=7 Participants
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
|---|---|---|---|
|
Change in Perceived Hunger
|
18.4 units on a scale
Standard Error 5.2
|
27.3 units on a scale
Standard Error 11.9
|
10.3 units on a scale
Standard Error 2.9
|
Adverse Events
Caloric Restriction and High Protein
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Caloric Restriction and Normal Protein
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Energy Balance
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caloric Restriction and High Protein
n=11 participants at risk
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 1.7 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Caloric Restriction and Normal Protein
n=9 participants at risk
Participants will be calorie restricted to 30 kcal/kg FFM/day and consume 0.8 g protein/kg BW/day.
Caloric Restriction: Participants will consume 30 kcal/kg FFM/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
Energy Balance
n=9 participants at risk
Participants will be in energy balance and consume 1.7 g protein/kg BW/day.
Protein: Participants will consume 1.7 g protein/kg BW/day.
Exercise: Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
Calcium and Vitamin D: Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
Maltodextrin: Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • During the course of the entire study (~1.5 years).
|
0.00%
0/9 • During the course of the entire study (~1.5 years).
|
11.1%
1/9 • Number of events 1 • During the course of the entire study (~1.5 years).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place