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RECRUITING Not applicable ClinicalTrials.gov

Lifestyle Intervention to Improve Muscle Function in Older Adults

Sponsor: Pennington Biomedical Research Center • ClinicalTrials.gov ID: NCT07597980

Registry updated: 2026-10-15
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Description

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.

Interventions

  • Structured nutrition plan (Behavioral)
    Participants will receive a structured nutrition plan.
  • Typical or usual diet (Behavioral)
    Participants will receive a diet representing the usual diet in this population.
  • Supervised Exercise (Behavioral)
    Participants will complete aerobic and resistance training under supervision three times per week.

Eligibility criteria

Inclusion Criteria: 1. Age \> 50 years. 2. Body mass index (BMI) ≥ 30 kg/m2. 3. Homeostatic model assessment of insulin resistance ≥ 3. 4. Mini-Mental State Examination (MMSE) \> 25. 5. Geriatric Depression Scale-15 (GDS-15) \< 9. 6. Sedentary (less than 90 minutes/week of moderate to vigorous activity). 7. Ability to provide written informed consent. Exclusion Criteria: 1. 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. 2. Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers. 3. Fluctuation in body weight \> 3 kg in the preceding two months 4. Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.

Conditions

Body Composition Physical Function Energy Balance

Locations

  • Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record