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Search / Trial NCT06845046

A Study to Improve Skeletal Muscle in Veterans With HIV

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Feb 19, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Hiv Obesity Skeletal Muscle Dietary Supplement

ClinConnect Summary

This clinical trial is designed to help improve muscle health in veterans living with HIV and obesity. Researchers have found that many veterans with these conditions have excess fat in their muscles, which can lead to problems like weakness, difficulty moving, and an increased risk of diseases such as diabetes and heart issues. To address this, the study will test a combination of approaches, including a healthier diet, specific supplements (like L-carnitine and omega-3 fatty acids), and targeted exercise training.

To participate in this trial, you must be a veteran who is HIV positive, has been on a specific HIV treatment for at least three months, and has a body mass index (BMI) between 28 and 50. Participants will undergo assessments to ensure they meet the criteria and can safely engage in physical activities. This trial will not only aim to improve muscle health but also help enhance overall physical function and well-being. If you meet the eligibility criteria and are interested, you can look forward to being part of a supportive program focused on improving your health.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Veteran
  • HIV+
  • antiretroviral therapy = integrase strand transfer inhibitor for at least 3 months
  • HIV-1 RNA \<50 copies/ml
  • age = 20 yrs
  • BMI 28-50 kg/m2
  • Exclusion Criteria:
  • unstable body weight (gain or loss \> 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 of \>6.5% at screening visit
  • inflammatory conditions or chronic corticosteroid use
  • stage 3 or greater kidney disease
  • 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
  • contradictions to CPET such as exercise-induced ischemia or supplemental oxygen

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Heidi J Silver, PhD

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

John R Koethe, MD

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported