Lifestyle Intervention to Improve Muscle Function in Older Adults

Trial statusNot yet recruiting
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

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

Treatments tested in this trial

  • Structured nutrition plan
  • Typical or usual diet
  • Supervised Exercise

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Pennington Biomedical Research Center

Lead sponsor

National Institute on Aging (NIA)

Collaborator