Effect of High Protein Weight Loss for Seniors

NCT02730988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-01-23

Study results available
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Summary

Intentional weight loss in obese, older adults remains controversial. Although caloric restriction, resulting in significant weight and fat mass loss, ameliorates many clinical consequences of obesity, recommendation of intentional weight loss in aging remains controversial. Reluctance stems, at least in part, from loss of lean and bone mass known to accompany overall weight loss and potential exacerbation of age-related risk of disability and fracture. Accordingly, current treatment guidelines call fhttp://google.wfu.edu/or weight-loss therapy that minimizes muscle and bone losses for older persons who are obese and who have functional impairments or medical complications that can benefit from weight loss.

Amount of dietary protein consumed during caloric restriction may be a key determinant in maintaining fat-free mass during weight loss. Adequate dietary protein is essential for skeletal muscle anabolism; and, epidemiological evidence in older adults point to a salutary effect of protein intake above the current RDA (0.8 g/kg/day) on body composition. Indeed, a recent position statement by the PRO-TAGE study group advises consumption of 1.0-1.2 g/kg/d in older adults during weight-stable conditions to aid in the maintenance of lean body mass and function. Practical achievement of this level of protein intake is often difficult for obese, older adults undergoing weight loss, yet may be critical to offset weight loss-associated lean mass loss. Preliminary data from our group show a lean mass sparing effect of high protein consumption during caloric restriction. In post-menopausal women undergoing a 5-month intentional weight loss program, consumption of a high (1.2 g/kg/day) versus low (0.6 g/kg/day) protein diet was associated with 50% attenuation (17% vs. 37%) of lean mass loss. While promising, results have yet to be translated to functional changes in a tightly controlled trial of weight loss in obese, older adults.

The primary goal of this study is to determine whether adherence to a high protein (≥1.0 g/kg/d) weight loss program results in improved physical function by favorably affecting body composition compared to weight stability in obese, older adults. This will be accomplished by conducting a 24-week trial in 124 obese (BMI 30-40 kg/m2), older (65-79 years) men and women, at risk for mobility disability, randomized to either: (1) high protein intake (≥1.0 g/kg/d; n=62) during weight loss, or (2) weight-stable control (n=62).

Conditions

Interventions

BEHAVIORAL

Weight Stable Group

The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff. If participants attend 75% of the educational sessions, all baseline and follow-up testing sessions, and maintain weight stability over the course of the study (defined as less than a 5% differential between weight measured at week 0 and 24), they will be eligible to receive up to 3 months of Medifast MRPs along with a 30-60 minute RD-led dietary instruction session on how to follow the Medifast 4 \& 2 \& 1 Plan.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER
  • Wake Forest University

    lead OTHER

Principal Investigators

  • Kristen M Beavers, PhD · Wake Forest University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2017-03-30
Completion
2017-04-17

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730988 on ClinicalTrials.gov