Utilizing Protein During Weight Loss to Impact Physical Function and Bone

NACompletedINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

May 3, 2017

Primary Completion Date

April 28, 2022

Study Completion Date

April 28, 2022

Conditions
ObesityWeight LossDiet ModificationAgingWeight Change, BodyDietary HabitsOsteopenia, OsteoporosisBone LossFractures, Bone
Interventions
BEHAVIORAL

Weight loss intervention months 0-6

All participants will undergo 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. The weight loss intervention will incorporate 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 will be held weekly in a 3:1 ratio (3 group and 1 individual session per month).

BEHAVIORAL

Exercise intervention months 0-6

All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults.

DIETARY_SUPPLEMENT

NutraBio™ CarboMax Supplement

Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (NutraBio™ CarboMax, \~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention.

DIETARY_SUPPLEMENT

6-month NutraBio™ 100% Whey Protein Isolate Supplement

Participants in the 6-month higher protein / lower CHO diet group (6-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, \~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention.

DIETARY_SUPPLEMENT

18-month NutraBio™ 100% Whey Protein Isolate Supplement

Participants in the 18-month higher protein / lower CHO diet (18-mo HiProt) will be provided a protein supplement (NutraBio™ 100% Whey Protein Isolate, \~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and the 12-month follow-up.

Trial Locations (1)

27157

Geriatric Research Center at Wake Forest Baptist Health, Winston-Salem

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

Wake Forest University Health Sciences

OTHER

NCT03819478 - Utilizing Protein During Weight Loss to Impact Physical Function and Bone | Biotech Hunter | Biotech Hunter