Lifestyle Intervention to Improve Muscle Function in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Structured nutrition plan, Typical or usual diet, Supervised Exercise.
- Who it may be relevant to
- Registry conditions: Body Composition, Physical Function, Energy Balance. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
In the United States nearly one third of adults over 60 years of age have sarcopenic obesity which encompasses the combined effect of muscle impairment and obesity. A strategy that addresses the combined effect of muscle impairment and obesity while modulating muscle mass and composition is an unanswered challenge. This 12-week study will evaluate the effects of a structured nutrition plan combined with an exercise program on body fat and muscle mass, lower-extremity function (Short Physical Performance Battery), muscle strength (handgrip and knee strength), and daily caloric intake. The study will enroll adults aged 50 years and older with obesity (body mass index ≥ 30 kg/m²) and insulin resistance as indicated by a homeostasis model assessment of insulin resistance (HOMA-IR) score ≥ 3. Subjects will be randomly allocated to receive the structured nutrition plan and exercise intervention or to their usual diet and exercise in equal numbers (40 per group). The study will enrich our understanding of the physiological adaptations necessary for effective lifestyle interventions to improve muscle function.
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.
Primary outcome measures
- Fat mass [Time frame: Change from baseline to 12 weeks]
Secondary outcome measures (10)
- Skeletal muscle mass [Time frame: Change in from baseline to 12 weeks]
- Short physical performance battery [Time frame: Change from baseline to 12 weeks]
- Hand-grip strength [Time frame: Change from baseline to 12 weeks]
- Knee strength [Time frame: Change from baseline to12 weeks]
- Energy stores [Time frame: 12 weeks]
- Hormonal regulation of energy balance [Time frame: Change from baseline to 12 weeks]
- Hormonal regulation of energy balance [Time frame: Change from baseline to 12 weeks]
- Hormonal regulation of energy balance [Time frame: Change from baseline to 12 weeks]
- Hormonal regulation of energy balance [Time frame: Change from baseline to 12 weeks]
- Cardiorespiratory fitness [Time frame: Change in VO2max from baseline to 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Pennington Biomedical Research Center — Baton Rouge
Identifiers
NCT: NCT07597980 · PBRC-2025-060 · 1R01AG092725-01A1