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Lifestyle Intervention to Improve Muscle Function in Older Adults

ConditionsBody CompositionPhysical FunctionEnergy Balance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorPennington Biomedical Research Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 50 years.

Body mass index (BMI) ≥ 30 kg/m2.

Homeostatic model assessment of insulin resistance ≥ 3.

Mini-Mental State Examination (MMSE) > 25.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Structured nutrition plan + exerciseExperimental treatment 2 interventions
Group B: Typical or usual diet + exerciseActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Fat mass

Fat mass measured by dual X-ray absorptiometry

Time frame
Change from baseline to 12 weeks

Secondary outcomes

1

Skeletal muscle mass

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

Time frame
Change in from baseline to 12 weeks
2

Short physical performance battery

A test of physical function

Time frame
Change from baseline to 12 weeks
3

Hand-grip strength

Hand grip strength will be measured using a hand dynamometer

Time frame
Change from baseline to 12 weeks
4

Knee strength

Knee strength will be measured quantified using Biodex dynamometry

Time frame
Change from baseline to12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pennington Biomedical Research Center

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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