Lifestyle Intervention to Improve Muscle Function in Older Adults

NCT07597980 | Not Yet Recruiting

• 2 other identifiers: PBRC-2025-0601R01AG092725-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Body Composition; Physical Function; Energy Balance

Keywords

Fat mass; muscle mass; physical function; energy deficit

Outcome Measures

Primary Outcomes (1)

• Fat mass

  Fat mass measured by dual X-ray absorptiometry

  Change from baseline to 12 weeks

Secondary Outcomes (10)

• Skeletal muscle mass

  Change in from baseline to 12 weeks

• Short physical performance battery

  Change from baseline to 12 weeks

• Hand-grip strength

  Change from baseline to 12 weeks

• Knee strength

  Change from baseline to12 weeks

• Energy stores

  12 weeks

Study Arms (2)

Structured nutrition plan + exercise

EXPERIMENTAL

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

Behavioral: Structured nutrition plan + exercise

Typical or usual diet + exercise

ACTIVE COMPARATOR

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

Other: Typical or usual diet + exercise

Interventions

Structured nutrition plan + exercise BEHAVIORAL

Participants will receive a structured nutrition plan. The exercise intervention will be the same in both groups.

Structured nutrition plan + exercise

Typical or usual diet + exercise OTHER

Participants will receive a diet representing the usual diet in this population. The exercise intervention will be the same in both groups.

Typical or usual diet + exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Candida J Rebello, PhD, RD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candida J Rebello, PhD, RD

CONTACT

12257633159; Candida.Rebello@pbrc.edu

Reilly Roberts A Project Manager, MS

CONTACT

225-763-2854; candidajoan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)