CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
Foods rich in high quality proteindietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03835416
NCT03835416N/ACompleted

Enhanced Protein Intake During Obesity Reduction in Older Male Veterans: Differences in Physical Function and Muscle Quality Responses by Race

VA Office of Research and Development·interventional·Posted Feb 8, 2019·Updated Jun 6, 2025

In Brief

A clinical study evaluating Foods rich in high quality protein for Prediabetes and Obesity. Completed, enrolled 105 participants across 1 site.

Detailed Summary

Diabetes is a major health concern in obese older Veterans, especially in those who are African American. The negative impact of diabetes on muscle and physical function contributes to metabolic as well as physical decline and is under-studied. This randomized controlled trial compares a higher-protein, weight loss regimen previously shown to improve physical function to an Recommended Dietary Allowance (RDA) protein intervention in obese older male Veterans with pre-diabetes and functional limitations. Equal numbers of white and black male Veterans will be studied, filling gaps in the investigators' knowledge of differential responses by race as well as obesity interventions for men in general. The primary outcome is functional performance by Short Physical Performance Battery and secondary measures include muscle quantity and composition, glucose handling, lean body mass, recent falls and fear of falling, and quality of life measured at 0, 3 and 6 months. The goal of this research is to accelerate functional recovery and enhance independence in obese male Veterans, which is strongly aligned with the VA mission to "maximize the physical and social autonomy of Veterans".

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrediabetes, Obesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 8, 2019
Enrollment StartDec 12, 2019
Primary CompletionMar 26, 2024
Study CompletionMar 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.4 years ago

Interventions

Foods rich in high quality proteindietary

Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description).