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Lifestyle Intervention to Improve Muscle Function in Older Adults

NCT07597980 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-22

No results posted yet for this study

Summary

The goal of this randomized controlled two-arm trial is to determine the effect of a diet and exercise intervention for 12 weeks on body composition, muscle function, and energy balance in 80 adults aged 50 years and over with obesity and insulin resistance. The main questions the trial aims to answer are: Will 12 weeks of a structured nutrition plan + exercise reduce fat mass, improve muscle function, and increase energy deficit compared to the usual diet + exercise. The hypothesis is that 12 weeks of a structured nutrition plan + exercise will reduce fat mass, improve muscle function, and produce greater energy deficit than the usual diet + exercise. Participants will be provided with all meals for 12 weeks and will exercise at the Center under supervision three times each week. Pre and post-intervention, body composition, physical function, and energy deficit will be measured.

Conditions

  • Body Composition
  • Physical Function
  • Energy Balance

Interventions

BEHAVIORAL

Structured nutrition plan

Participants will receive a structured nutrition plan.

BEHAVIORAL

Typical or usual diet

Participants will receive a diet representing the usual diet in this population.

BEHAVIORAL

Supervised Exercise

Participants will complete aerobic and resistance training under supervision three times per week.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Candida J Rebello, PhD, RD · Pennington Biomedical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • United States

Study Locations

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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 NCT07597980 on ClinicalTrials.gov