Lifestyle Intervention to Improve Muscle Function in Older Adults

Recruiting now · Not applicable

Conditions studied: Body Composition, Physical Function, Energy Balance

In brief

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.

Key facts

Study ID

NCT07597980

Run by

Pennington Biomedical Research Center

People needed

80

Starts

2026-07-01

Expected to finish

2030-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 50 years.
• Body mass index (BMI) ≥ 30 kg/m2.
• Homeostatic model assessment of insulin resistance ≥ 3.
• Mini-Mental State Examination (MMSE) > 25.
• Geriatric Depression Scale-15 (GDS-15) < 9.
• Sedentary (less than 90 minutes/week of moderate to vigorous activity).
• Ability to provide written informed consent.

You may not qualify if…

• Diagnosis of cancer (received within five years) or diabetes (type 1 and 2), or significant musculoskeletal, or cardiovascular, or hepatic, or renal, disease or dysfunction.
• Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers.
• Fluctuation in body weight > 3 kg in the preceding two months
• Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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