An interventional study of w-3 fatty acid and L-carnitine in HIV and Obesity, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to male participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
The Department of Veterans Affairs is the largest single provider of medical care to people with HIV in the United States. With the advances achieved in antiretroviral therapy (ART), Veterans with HIV now survive decades. However, this success is tempered by the rising burden of obesity now affecting 78% of Veterans. Defects in adipose tissue lipid storage and regulation are hallmarks of both treated HIV and obesity, which leads to a high degree of ectopic fat infiltrating organs and tissues such as skeletal muscle. 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". Further, the investigators found that high ectopic fat accumulation in muscle (quantified by CT imaging of skeletal muscle density) is associated with reduced mitochondrial oxidative capacity, greater inflammation, and impaired muscle glucose tolerance and insulin sensitivity. Hence the quality of muscle is just as important as the quantity of muscle. However, this important phenomenon has received little attention, especially in Veterans with HIV. Indeed, the need to target mobilizing and metabolizing skeletal muscle ectopic fat while preserving/increasing the total amount of skeletal muscle is most often overlooked and represents a major research gap and unmet clinical need. From the investigators current Merit Award funded study, the investigators have an established collaboration of experienced VA researchers with expertise in HIV and immunology, human nutrition and metabolism, endocrinology, radiology and imaging science, and muscle physiology. 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. This evidence-based intervention is designed to: a) increase lipid flux by facilitating the transfer of long-chain fatty acids into muscle mitochondria for -oxidation; b) decrease muscle proteolysis; and c) lessen insulin resistance and inflammation. Using a mixed 2x4 factorial design trial design in a cohort of 60 Veterans who have HIV and obesity, this study will determine the main and interaction effects of the multi-pronged intervention on: skeletal muscle density, mitochondrial oxidative capacity, and fatty acid oxidation (Aim 1); glucose tolerance, insulin sensitivity, and inflammation (Aim 2); and cardiopulmonary exercise tolerance and physical function (Aim 3). Obesity in Veterans with treated HIV is a heterogeneous condition. The investigators current Merit research shows myosteatotic obesity is a distinct condition from visceral or steatotic or sarcopenic obesity, affected by different clinical factors. The investigators findings to date provide the foundation for a novel evidence-based intervention that has the potential for significant clinical impact on Veterans, including and beyond those with HIV. This proposal meets VA-ORD priorities to improve health behaviors, focus on underserved Veterans, and provide precision care.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 70 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diet high in unsaturated fat
Other: Control Diet
Diet high in unsaturated fat plus omega-3 fatty acid supplement
Dietary Supplement: w-3 fatty acid · Other: Control Diet
Diet high in unsaturated fat plus L-carnitine supplement
Dietary Supplement: L-carnitine · Other: Control Diet
Diet high in unsaturated fat plus omega-3 fatty acid supplement plus L-carnitine supplement
Dietary Supplement: w-3 fatty acid · Dietary Supplement: L-carnitine · Other: Control Diet
omega-3 fatty acid supplement
L-carnitine supplement
Control Diet high in unsaturated fat
Myosteatosis
CT quantified abdominal skeletal muscle density
Time frame: Week 24 and 44
MixedMeal GTT
IV Glucose tolerance testing after consumption of BOOST as a meal substitute
Time frame: Week 24 and 44
Physical Function
Physical Function Testing using Hand Grip Strength Dynamometer
Time frame: Week 24 and 44
Plan to share: No
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VA Office of Research and Development