Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
MALE
ID06845046

A Randomized Trial to Optimize Skeletal Muscle While Reducing Adiposity in Veterans With HIV

Led by VA Office of Research and Development · Updated on 2025-07-30

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying Veterans who have HIV and obesity, focusing on a condition called myosteatosis, where excess fat builds up in and around muscles. This fat buildup can lead to problems like reduced physical function, frailty, disability, and diseases such as diabetes and heart disease. The study aims to evaluate a new combined approach to improve muscle health and reduce fat in these Veterans using diet, supplements, and exercise. The study tests a multi-part intervention that includes replacing saturated fats in the diet with unsaturated fats, taking L-carnitine and omega-3 fatty acid supplements, and doing specific resistance exercise training. Participants are randomly assigned to one of four groups: a control diet high in unsaturated fat, diet plus omega-3 supplements, diet plus L-carnitine supplements, or diet combined with both supplements. This approach is designed to improve muscle fat metabolism, reduce muscle breakdown, and lower insulin resistance and inflammation. Participants will be involved for 44 weeks, with assessments at weeks 24 and 44 to measure muscle fat content, glucose tolerance, insulin sensitivity, inflammation, and physical function. Researchers will use tests including mixed meal glucose tolerance tests and physical function evaluations. The study will monitor changes in muscle quality, metabolic health, and exercise capacity to understand the effects of the combined intervention on Veterans living with HIV and obesity.

CONDITIONS

Brief Title

A Study to Improve Skeletal Muscle in Veterans With HIV

Who Can Participate

Age: 20Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Veteran
  • Diagnosed with HIV
  • On integrase strand transfer inhibitor antiretroviral therapy for at least 3 months
  • HIV-1 RNA less than 50 copies/ml
  • Age between 20 and 80 years
  • Body mass index (BMI) between 28 and 50 kg/m2
Not Eligible

You will not qualify if you...

  • Unstable body weight with gain or loss greater than 5% over past 3 months
  • Diagnosed mitochondrial disorder
  • Diagnosed type 1 or type 2 diabetes
  • Use of metformin or other anti-diabetic agents for pre-diabetes
  • Hemoglobin A1c greater than 6.5% at screening visit
  • Inflammatory conditions or chronic corticosteroid use
  • Stage 3 or greater kidney disease
  • Use of dietary or herbal supplements known to affect body weight, muscle mass, or immune function
  • MRI incompatibility
  • Inability to perform physical function tests due to anatomical limitations
  • Contraindications to cardiopulmonary exercise testing such as exercise-induced ischemia or need for supplemental oxygen

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 24 weeks

Participants follow a diet high in unsaturated fat combined with supplements of omega-3 fatty acids and/or L-carnitine, along with targeted resistance exercise training to improve skeletal muscle quality and reduce adiposity.

Regular visits for assessments at Weeks 24 and 44

Follow-up

Duration - 20 weeks

Participants continue to be monitored after the treatment period to assess lasting effects on muscle quality, glucose tolerance, and physical function.

Visits at Week 44 for final assessments

Trial Site Locations

Total: 1 location

1

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States, 37212-2637

Actively Recruiting

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Research Team

H

Heidi J Silver, PhD

J

John R Koethe, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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