Diet + Exercise for Muscle Function

Overseen By Reilly Roberts A Project Manager, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Disqualifiers: Cancer, Diabetes, Musculoskeletal, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Candida J Rebello, PhD, RD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for adults over 50 who have obesity (BMI of 30 or higher), show signs of insulin resistance, are mostly sedentary, and do not have significant memory problems or depression. Participants must be able to give consent.

Inclusion Criteria

Body mass index (BMI) ≥ 30 kg/m2

Homeostatic model assessment of insulin resistance ≥ 3

Mini-Mental State Examination (MMSE) > 25

Exclusion Criteria

Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods

I have had cancer in the past five years or have diabetes or major organ disease.

I do not have serious digestive problems like chronic diarrhea or celiac disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a structured nutrition plan and exercise under supervision for 12 weeks

12 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Structured nutrition plan
• Supervised Exercise

Trial Overview

The study compares a structured nutrition plan plus supervised exercise versus usual diet plus the same exercise routine over 12 weeks. All meals are provided, and participants exercise three times per week at the center.

How Is the Trial Designed?

Group I: Structured nutrition plan + exercise Experimental Treatment 2 Interventions

Intervention: Participants receive a structured nutrition plan, and exercise under supervision.

Group II: Typical or usual diet + exercise Active Control 2 Interventions

Participants receive a typical or usual diet, and exercise under supervision

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+