Recruiting

Nutrition Plan & Exercise

Sponsor:

Pennington Biomedical Research Center

Code:

NCT07597980

Conditions

Body Composition

Physical Function

Energy Balance

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Structured nutrition plan

Typical or usual diet

Supervised Exercise

Study Details

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

Study ID

NCT07597980

Start date

Jul 20, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age > 50 years.
2. Body mass index (BMI) ≥ 30 kg/m2.
3. Homeostatic model assessment of insulin resistance ≥ 3.
4. Mini-Mental State Examination (MMSE) > 25.
5. Geriatric Depression Scale-15 (GDS-15) < 9.
6. Sedentary (less than 90 minutes/week of moderate to vigorous activity).
7. Ability to provide written informed consent.

Exclusion Criteria:

1. 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.
2. Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers.
3. Fluctuation in body weight > 3 kg in the preceding two months
4. Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Structured nutrition plan + exercise

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

active comparator: Typical or usual diet + exercise

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

Interventions

Structured nutrition plan

Participants will receive a structured nutrition plan.

Typical or usual diet

Participants will receive a diet representing the usual diet in this population.

Supervised Exercise

Participants will complete aerobic and resistance training under supervision three times per week.

Primary outcome measure

  • Fat mass [ Time Frame: Change from baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Candida J Rebello, PhD, RD

12257633159Candida.Rebello@pbrc.edu

Reilly Roberts A Project Manager, MS

225-763-2854candidajoan@hotmail.com

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Candida J Rebello, PhD, RD

225-763-3159Candida.Rebello@pbrc.edu

Reilly Roberts A Project Manager, MS

225-763-2854Reilly.Roberts@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Sep 3, 2026

Last verified

Jul, 2026

Keywords

  • Fat mass
  • muscle mass
  • physical function
  • energy deficit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2026-09-03.