Utilizing Protein During Weight Loss to Impact Physical Function and Bone

Summary

This study is an ancillary study to the Utilizing Protein During Weight Loss to Impact Physical Function (UPLIFT) trial (NCT03074643) to evaluate the effects of diet composition (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on bone phenotypes in obese older adults. Participants will receive either a protein or carbohydrate supplement along with a behavioral weight loss intervention.

Conditions

• Obesity
• Weight Loss
• Diet Modification
• Aging
• Weight Change, Body
• Dietary Habits
• Osteopenia, Osteoporosis
• Bone Loss
• Fractures, 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.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Ashley Weaver, PhD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-03

Primary Completion

2022-04-28

Completion

2022-04-28

Countries

• United States

Study Locations