Health TrialsbyHealthPanel

A Study to Improve Skeletal Muscle in Veterans With HIV

ConditionsHIVObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20-80
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veteran

HIV+

antiretroviral therapy = integrase strand transfer inhibitor for at least 3 months

HIV-1 RNA <50 copies/ml

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • w-3 fatty acid

    Dietary supplement

    omega-3 fatty acid supplement

  • L-carnitine

    Dietary supplement

    L-carnitine supplement

  • Control Diet

    Other intervention

    Control Diet high in unsaturated fat

Treatment groups

70 Participants
are divided into 4 treatment groups
Group A: Control DietPlacebo comparator 1 intervention
Group B: Diet + w-3 fatty acidsExperimental treatment 2 interventions
Group C: Diet + L-CarnitineExperimental treatment 2 interventions
Group D: Diet + w-3 fatty acids + L-carnitineExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Myosteatosis

CT quantified abdominal skeletal muscle density

Time frame
Week 24 and 44
2

MixedMeal GTT

IV Glucose tolerance testing after consumption of BOOST as a meal substitute

Time frame
Week 24 and 44
3

Physical Function

Physical Function Testing using Hand Grip Strength Dynamometer

Time frame
Week 24 and 44

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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