RECRUITING

A Study to Improve Skeletal Muscle in Veterans With HIV

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-15
Study Completion:2029-06-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06845046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 80 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran
  2. * HIV+
  3. * antiretroviral therapy = integrase strand transfer inhibitor for at least 3 months
  4. * HIV-1 RNA \<50 copies/ml
  5. * age = 20 yrs
  6. * BMI 28-50 kg/m2
  1. * unstable body weight (gain or loss \> 5% over past 3 months)
  2. * diagnosed mitochondrial disorder
  3. * diagnosed type 1 or type 2 diabetes
  4. * use of metformin or other anti-diabetic agents for pre-diabetes
  5. * hemoglobin A1c of \>6.5% at screening visit
  6. * inflammatory conditions or chronic corticosteroid use
  7. * stage 3 or greater kidney disease
  8. * dietary or herbal supplements known to affect body weight, muscle mass, or immune function
  9. * MRI incompatibility
  10. * inability to perform physical function tests due to anatomical limitations
  11. * contradictions to CPET such as exercise-induced ischemia or supplemental oxygen

Contacts and Locations

Study Contact

Heidi J Silver, PhD
CONTACT
(615) 875-9355
heidi.j.silver@vumc.org
John R Koethe, MD
CONTACT
(615) 873-6188
john.koethe@va.gov

Principal Investigator

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

Study Locations (Sites)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-15
Study Completion Date2029-06-29

Study Record Updates

Study Start Date2025-07-15
Study Completion Date2029-06-29

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • obesity
  • skeletal muscle
  • dietary supplement

Additional Relevant MeSH Terms

  • HIV
  • Obesity