Lifestyle Intervention to Improve Muscle Function in Older Adults

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Pennington Biomedical Research Center
Study ID
NCT07597980
Status
Not Yet Recruiting

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Conditions

  • Body Composition
  • Energy Balance
  • Physical Function

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Structured nutrition plan + exercise
    Intervention: Participants receive a structured nutrition plan, and exercise under supervision.
  • Active Comparator: Typical or usual diet + exercise
    Participants receive a typical or usual diet, and exercise under supervision

Primary Outcome Measure

Fat mass [ Time Frame: Change from baseline to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pennington Biomedical Research CenterBaton RougeLouisiana70808
Candida J Rebello, PhD, RD
225-763-3159
Reilly Roberts A Project Manager, MS
225-763-2854

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