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NCT Number: NCT07597980

Lifestyle Intervention to Improve Muscle Function in Older Adults

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.

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Key information

Conditions

Body Composition Energy Balance Physical Function

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Fat mass

    Time frame: Change from baseline to 12 weeks

    Fat mass measured by dual X-ray absorptiometry

Secondary outcomes

  1. Skeletal muscle mass

    Time frame: Change in from baseline to 12 weeks

    Skeletal muscle mass will be measured by the creatine methyl D-3 dilution method

  2. Short physical performance battery

    Time frame: Change from baseline to 12 weeks

    A test of physical function

  3. Hand-grip strength

    Time frame: Change from baseline to 12 weeks

    Hand grip strength will be measured using a hand dynamometer

  4. Knee strength

    Time frame: Change from baseline to12 weeks

    Knee strength will be measured quantified using Biodex dynamometry

  5. Energy stores

    Time frame: 12 weeks

    Change in energy stores/day (kcal) determined from measures of body composition using the energy balance method

  6. Hormonal regulation of energy balance

    Time frame: Change from baseline to 12 weeks

    Blood concentrations of glucagon-like peptide 1

  7. Hormonal regulation of energy balance

    Time frame: Change from baseline to 12 weeks

    Blood concentrations of gastric inhibitory peptide

  8. Hormonal regulation of energy balance

    Time frame: Change from baseline to 12 weeks

    Blood concentrations of cortisol

  9. Hormonal regulation of energy balance

    Time frame: Change from baseline to 12 weeks

    Blood concentrations of leptin

  10. Cardiorespiratory fitness

    Time frame: Change in VO2max from baseline to 12 weeks

    VO2max

Study contacts

Contact information is provided by the study sponsor or research team.

Candida J Rebello, PhD, RD

CONTACT

[email protected]

12257633159

Reilly Roberts A Project Manager, MS

CONTACT

[email protected]

225-763-2854

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 20, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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