Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
MALE
NCT06845046

A Study to Improve Skeletal Muscle in Veterans With HIV

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

70

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The Department of Veterans Affairs is the largest single provider of medical care to people with HIV in the United States. The condition of excess lipid within and around muscle, termed myosteatosis, predisposes Veterans to physical function decline, frailty, disability, and cardiometabolic diseases such as diabetes and cardiovascular disease. In the investigators current Merit supported cohort, the investigators found that 36% of Veterans with treated HIV and obesity have "myosteatotic type obesity". Based on the investigators findings, the investigators have designed a multipronged integrated intervention that combines: 1) dietary replacement of saturated with unsaturated fats; 2) administration of L-carnitine and omega-3 fatty acid supplementation; and 3) targeted resistance exercise training.

CONDITIONS

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

You will not qualify if you...

  • Unstable body weight with more than 5% gain or loss in past 3 months
  • Diagnosed mitochondrial disorder
  • Diagnosed type 1 or type 2 diabetes
  • Use of metformin or other anti-diabetic drugs for pre-diabetes
  • Hemoglobin A1c greater than 6.5% at screening
  • Inflammatory conditions or chronic corticosteroid use
  • Stage 3 or higher kidney disease
  • Use of dietary or herbal supplements affecting 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

J

John R Koethe, MD

CONTACT

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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