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Lifestyle Intervention to Improve Muscle Function in Older Adults

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion moved earlier from Dec 2030 to Jun 2030
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 10 entries
  2. Start date changed from estimate of Jul 2026 to Jul 20, 2026v4
  3. Recruitment opened
    • Start date: Jun 2026 to Jul 2026
    • Site details revised
    v3
  4. Interventions: Structured nutrition plan + exercise (Behavioral), Typical or usual diet + exercise (Other) to Structured nutrition plan (Behavioral), Supervised Exercise (Behavioral), Typical or usual diet (Behavioral)v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07597980
Lead Sponsor Pennington Biomedical Research Center
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)		 Body Composition, Physical Function, Energy Balance
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov