Trial Outcomes & Findings for Utilizing Protein During Weight Loss to Impact Physical Function and Bone (NCT NCT03819478)
NCT ID: NCT03819478
Last Updated: 2024-01-19
Results Overview
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in total hip trabecular volumetric bone mineral density (vBMD). Total hip trabecular vBMD (in mg/cm\^3) was measured from the baseline and 18-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vBMD measures. The 18-month change in total hip trabecular vBMD from baseline is reported for this outcome measure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
187 participants
Primary outcome timeframe
Change from Baseline to Month 18
Results posted on
2024-01-19
Participant Flow
Participant milestones
| Measure |
RecProt
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
62
|
63
|
|
Overall Study
COMPLETED
|
51
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Utilizing Protein During Weight Loss to Impact Physical Function and Bone
Baseline characteristics by cohort
| Measure |
RecProt
n=62 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=62 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
n=63 Participants
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 4.4 • n=5 Participants
|
71.8 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
71.0 years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Body mass index (BMI)
|
33.8 kg/m^2
STANDARD_DEVIATION 4.6 • n=5 Participants
|
34.3 kg/m^2
STANDARD_DEVIATION 3.5 • n=7 Participants
|
34.3 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
34.2 kg/m^2
STANDARD_DEVIATION 4.1 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Month 18To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in total hip trabecular volumetric bone mineral density (vBMD). Total hip trabecular vBMD (in mg/cm\^3) was measured from the baseline and 18-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vBMD measures. The 18-month change in total hip trabecular vBMD from baseline is reported for this outcome measure.
Outcome measures
| Measure |
RecProt
n=38 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=38 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
n=38 Participants
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
18-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3
|
-0.91 mg/cm^3
Standard Error 1.34
|
-1.77 mg/cm^3
Standard Error 1.40
|
-0.03 mg/cm^3
Standard Error 1.44
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: The two protein supplement groups ("6-mo HiProt" and "18-mo HiProt") are combined into a single "HiProt" group as both groups received the same intervention for months 0-6, and this outcome measure is reporting the change from Baseline to Month 6.
Percentage of adipose tissue within the lumbar spine bone marrow as assessed by a dual-energy computed tomography (CT) algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet. Percentage of adipose tissue within the bone marrow was measured from the baseline and 6-month dual-energy CT scans using a Mindways Model 3 phantom for calibration. The 6-month change in percentage of adipose tissue within the lumbar spine bone marrow from baseline is reported for this outcome measure.
Outcome measures
| Measure |
RecProt
n=41 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=89 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
6-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm
|
7.42 percentage of bone marrow adiposity
Standard Error 4.06
|
6.45 percentage of bone marrow adiposity
Standard Error 3.81
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 18Percentage of adipose tissue within the lumbar spine bone marrow as assessed by a dual-energy computed tomography (CT) algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet. Percentage of adipose tissue within the bone marrow was measured from the baseline and 18-month dual-energy CT scans using a Mindways Model 3 phantom for calibration. The 18-month change in percentage of adipose tissue within the lumbar spine bone marrow from baseline is reported for this outcome measure.
Outcome measures
| Measure |
RecProt
n=36 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=39 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
n=38 Participants
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
18-month Change From Baseline in Percentage of Adipose Tissue Within the Lumbar Spine Bone Marrow as Assessed by Dual-energy Computed Tomography Algorithm
|
-0.20 percentage of bone marrow adiposity
Standard Error 3.69
|
-9.96 percentage of bone marrow adiposity
Standard Error 3.80
|
-5.17 percentage of bone marrow adiposity
Standard Error 3.93
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: The two protein supplement groups ("6-mo HiProt" and "18-mo HiProt") are combined into a single "HiProt" group as both groups received the same intervention for months 0-6, and this outcome measure is reporting the change from Baseline to Month 6.
Subject-specific finite element models were created from the baseline and 6-month CT scans and femoral bone strength was assessed from a simulated test of a sideways fall. Bone strength was measured as the peak section force extracted at the femoral neck to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in femoral bone strength.
Outcome measures
| Measure |
RecProt
n=42 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=87 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
6-month Change From Baseline in Femoral Bone Strength in kN
|
-0.02 kN
Standard Error 0.08
|
0.10 kN
Standard Error 0.07
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 18Subject-specific finite element models were created from the baseline and 18-month CT scans and femoral bone strength was assessed from a simulated test of a sideways fall. Bone strength was measured as the peak section force extracted at the femoral neck to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in femoral bone strength.
Outcome measures
| Measure |
RecProt
n=38 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=38 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
n=38 Participants
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
18-month Change From Baseline in Femoral Bone Strength in kN
|
-0.02 kN
Standard Error 0.10
|
0.03 kN
Standard Error 0.11
|
0.09 kN
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 18Cortical thickness of the proximal femur was assessed by a computed tomography (CT) based algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in femoral cortical thickness. Cortical thickness was measured from the baseline and 18-month CT scans, and the 18-month change from baseline (in mm) is reported for this outcome measure.
Outcome measures
| Measure |
RecProt
n=41 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=42 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
n=42 Participants
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
18-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm
|
0.02 mm
Standard Error 0.02
|
0.02 mm
Standard Error 0.02
|
0.01 mm
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: The two protein supplement groups ("6-mo HiProt" and "18-mo HiProt") are combined into a single "HiProt" group as both groups received the same intervention for months 0-6, and this outcome measure is reporting the change from Baseline to Month 6.
Cortical thickness of the proximal femur was assessed by a computed tomography (CT) based algorithm to determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in femoral cortical thickness. Cortical thickness was measured from the baseline and 6-month CT scans, and the 6-month change from baseline (in mm) is reported for this outcome measure.
Outcome measures
| Measure |
RecProt
n=46 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=96 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
6-month Change From Baseline in Femoral Cortical Thickness Assessed by Computed Tomography (CT) in mm
|
0.01 mm
Standard Error 0.02
|
0.01 mm
Standard Error 0.02
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 18To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 18-month change from baseline in vertebral volumetric bone mineral density (vBMD) in the lumbar spine. Trabecular vBMD (in mg/cm\^3) was measured from the baseline and 18-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vertebral vBMD measures. The 18-month change in vertebral vBMD in the lumbar spine from baseline is reported for this outcome measure.
Outcome measures
| Measure |
RecProt
n=42 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=44 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
n=48 Participants
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
18-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3
|
-1.40 mg/cm^3
Standard Error 1.48
|
-0.39 mg/cm^3
Standard Error 1.54
|
-2.59 mg/cm^3
Standard Error 1.57
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: The two protein supplement groups ("6-mo HiProt" and "18-mo HiProt") are combined into a single "HiProt" group as both groups received the same intervention for months 0-6, and this outcome measure is reporting the change from Baseline to Month 6.
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in vertebral volumetric bone mineral density (vBMD) in the lumbar spine. Trabecular vBMD (in mg/cm\^3) was measured from the baseline and 6-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vertebral vBMD measures. The 6-month change in vertebral vBMD in the lumbar spine from baseline is reported for this outcome measure.
Outcome measures
| Measure |
RecProt
n=49 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=108 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
6-month Change From Baseline in Vertebral Volumetric Bone Mineral Density in the Lumbar Spine Assessed by Computed Tomography (CT) in mg/cm^3
|
2.87 mg/cm^3
Standard Error 1.48
|
3.56 mg/cm^3
Standard Error 1.41
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to Month 6Population: The two protein supplement groups ("6-mo HiProt" and "18-mo HiProt") are combined into a single "HiProt" group as both groups received the same intervention for months 0-6, and this outcome measure is reporting the change from Baseline to Month 6.
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet on the 6-month change from baseline in total hip trabecular volumetric bone mineral density (vBMD). Total hip trabecular vBMD (in mg/cm\^3) was measured from the baseline and 6-month quantitative CT scans using the Mindways Model 3 phantom to calibrate the vBMD measures. The 6-month change in total hip trabecular vBMD from baseline is reported for this outcome measure.
Outcome measures
| Measure |
RecProt
n=42 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=87 Participants
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
6-month Change From Baseline in Total Hip Trabecular Volumetric Bone Mineral Density Assessed by Computed Tomography (CT) in mg/cm^3
|
0.34 mg/cm^3
Standard Error 1.12
|
1.59 mg/cm^3
Standard Error 1.05
|
—
|
Adverse Events
RecProt
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
6-mo HiProt
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
18-mo HiProt
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RecProt
n=62 participants at risk
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=62 participants at risk
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
n=63 participants at risk
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/62 • 18 months
|
0.00%
0/62 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/62 • 18 months
|
0.00%
0/62 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Cardiac disorders
Myocardial Infarction
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Immune system disorders
Anaphylaxis
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Infections and infestations
Lung Infection
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 2 • 18 months
|
0.00%
0/63 • 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Nervous system disorders
Cognitive Disturbance
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Surgical and medical procedures
Knee Replacement
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Surgical and medical procedures
Transurethral Resection Of Prostrate
|
0.00%
0/62 • 18 months
|
0.00%
0/62 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Shoulder Replacement
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Surgical and medical procedures
Revision of Knee Replacement
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Surgical and medical procedures
Hip Replacement
|
0.00%
0/62 • 18 months
|
0.00%
0/62 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Umbilical Hernia Repair
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Surgical and medical procedures
Reverse Shoulder Arthroplasty
|
0.00%
0/62 • 18 months
|
0.00%
0/62 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
RecProt
n=62 participants at risk
Subjects receiving the following interventions in the parent trial (NCT03074643): Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
NutraBio™ CarboMax Supplement: Participants in the RecProt group were provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate, 220 calories) to consume daily during the 6 month weight loss intervention.
|
6-mo HiProt
n=62 participants at risk
Subjects receiving the following interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
6-month NutraBio™ 100% Whey Protein Isolate Supplement: 6-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g of protein, 220 calories) to consume daily during the 6 month weight loss intervention.
|
18-mo HiProt
n=63 participants at risk
Subjects received these interventions in the parent trial (NCT03074643): Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for months 7-18.
Weight loss intervention months 0-6: All participants underwent a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a \~10% loss of initial body mass. Weight loss intervention incorporated nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions held weekly in a 3:1 ratio (3 group: 1 individual session/month).
Exercise intervention months 0-6: All participants participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (treadmill walking) 3 d/wk during the 6-month weight loss intervention in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendations for older adults.
18-month NutraBio™ 100% Whey Protein Isolate Supplement: 18-mo HiProt participants provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, 50 g protein, 220 calories) to consume daily for the 18 months.
|
|---|---|---|---|
|
Infections and infestations
Sinusitis
|
11.3%
7/62 • Number of events 8 • 18 months
|
3.2%
2/62 • Number of events 2 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Infections and infestations
Upper Respiratory Infection
|
1.6%
1/62 • Number of events 1 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
6.3%
4/63 • Number of events 5 • 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
11.3%
7/62 • Number of events 9 • 18 months
|
9.7%
6/62 • Number of events 6 • 18 months
|
6.3%
4/63 • Number of events 4 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/62 • 18 months
|
11.3%
7/62 • Number of events 7 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.5%
4/62 • Number of events 4 • 18 months
|
4.8%
3/62 • Number of events 3 • 18 months
|
3.2%
2/63 • Number of events 2 • 18 months
|
Additional Information
Ashley Weaver, PhD
Wake Forest University Health Sciences
Phone: 336-716-0944
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place