Utilizing Protein During Weight Loss to Impact Physical Function

Summary

This study will 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 physical function, muscle mass, and weight loss maintenance 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

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

Carbohydrate supplement for months 0-6

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

DIETARY_SUPPLEMENT

Protein supplement for months 0-6

Participants in the higher protein / lower CHO diet groups (6-mon HiProt and 18-mon HiProt) will be provided a protein supplement (\~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention.

DIETARY_SUPPLEMENT

Protein supplement for follow-up months 7-18

Participants in the higher protein / lower CHO diet (18-mon HiProt) will be provided a protein supplement (\~50 g of protein and 220 calories) to consume daily during the 12-month follow-up.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Denise Houston, 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