RightFit
RecruitingNot applicable

A Study to Improve Skeletal Muscle in Veterans With HIV

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
20 Years to 80 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a plan to improve muscle health in Veterans with HIV and obesity. The plan combines replacing saturated fats with unsaturated fats, taking L-carnitine and omega-3 supplements, and doing strength exercises. It aims to address extra fat in and around muscles.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a Veteran.
  • You have HIV.
  • You have taken an HIV medicine called an integrase inhibitor for at least 3 months.
  • Your HIV blood level is below 50 copies per milliliter.
  • The listed age requirement is 20 years old.
  • Your BMI, a measure of weight compared with height, is 28–50.

Who can't join

  • Your weight has gone up or down by more than 5% in the past 3 months.
  • You have a diagnosed mitochondrial disorder, which affects how cells make energy.
  • You have type 1 or type 2 diabetes, take diabetes medicine for prediabetes, or have an A1c above 6.5% at screening. A1c measures average blood sugar.
  • You have a condition that causes inflammation or use corticosteroid medicines long term.
  • You have stage 3 or more advanced kidney disease.
  • You take diet or herbal supplements known to affect weight, muscle size, or the body's ability to fight illness.
  • You cannot safely have an MRI scan.
  • Your body has limits that prevent physical function tests, or an exercise test is unsafe for you—for example, because exercise reduces blood flow to your heart or you use extra oxygen.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TN