Fatty Acid + L-Carnitine for Obesity

Overseen By John R Koethe, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: VA Office of Research and Development

Must be taking: Integrase inhibitors

Must not be taking: Anti-diabetic agents

Disqualifiers: Diabetes, Kidney disease, Inflammatory conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 44 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use metformin or other anti-diabetic agents, or if you take dietary or herbal supplements that affect body weight, muscle mass, or immune function.

Is the combination of Fatty Acid and L-Carnitine safe for humans?

There is no specific safety data available for the combination of Fatty Acid and L-Carnitine in the provided research articles. ^{1 2 3 4 5}

How does the treatment of L-carnitine and omega-3 fatty acids for obesity differ from other treatments?

This treatment is unique because it combines L-carnitine, which helps transport fats into cells to be burned for energy, with omega-3 fatty acids, known for their heart health benefits. This combination aims to enhance fat metabolism and provide cardiovascular benefits, which is different from many other obesity treatments that focus solely on weight loss. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment L-carnitine and omega-3 fatty acids for obesity?

Research suggests that omega-3 fatty acids may help reduce obesity by suppressing appetite, improving circulation, and enhancing fat metabolism. Some studies have shown potential benefits of omega-3 supplementation for weight loss, especially when combined with a low-calorie diet or exercise. ^{11 12 13 14 15}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for Veterans with HIV and obesity (BMI 28-50), aged at least 20, who have been on specific antiretroviral therapy for over three months. They must have stable body weight and no diabetes, severe kidney disease, mitochondrial disorders, or conditions that limit physical tests.

Inclusion Criteria

Veteran

HIV+

I am 20 years old or older.

Exclusion Criteria

Unstable body weight (gain or loss > 5% over past 3 months)

MRI incompatibility

I cannot do certain physical tests because of my body's limitations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a multipronged integrated intervention including dietary changes, supplementation, and resistance exercise training

44 weeks

Regular visits for intervention monitoring and adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• L-carnitine
• w-3 fatty acid

Trial Overview The study aims to improve muscle health in participants by testing a diet high in unsaturated fats along with L-carnitine and omega-3 fatty acid supplements. It also includes targeted resistance exercise training as part of the intervention.

How Is the Trial Designed?

Group I: Diet + w-3 fatty acids + L-carnitine Experimental Treatment 3 Interventions

Diet high in unsaturated fat plus omega-3 fatty acid supplement plus L-carnitine supplement

Group II: Diet + w-3 fatty acids Experimental Treatment 2 Interventions

Diet high in unsaturated fat plus omega-3 fatty acid supplement

Group III: Diet + L-Carnitine Experimental Treatment 2 Interventions

Diet high in unsaturated fat plus L-carnitine supplement

Group IV: Control Diet Placebo Group 1 Intervention

Diet high in unsaturated fat

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

New generation anti-obesity medications, such as orlistat, phentermine/topiramate, and liraglutide 3.0 mg, have varying safety profiles, with some presenting significant risks like fetal toxicity and gallstone disease, while others mainly cause transient tolerability issues.

Despite their effectiveness in weight loss, the prescription rates for these medications are low, partly due to safety concerns and the need for more long-term data to better understand their risk-benefit profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. Patel, DK., Stanford, FC.[2023]

A total of 25 anti-obesity medications were withdrawn between 1964 and 2009, primarily due to adverse reactions related to their effects on monoamine neurotransmitters, with 80% of withdrawals supported by case reports.

The most common reasons for withdrawal included psychiatric disturbances, cardiotoxicity, and drug dependence, raising concerns about the safety of using medications that target neurotransmitters for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

Recent anti-obesity medications have been linked to adverse cardiovascular outcomes, prompting a need for thorough cardiovascular safety evaluations in clinical trials.

Current cardiovascular outcome trials for weight loss medications, including novel diabetes treatments, show limited data and unsatisfactory results, highlighting the need for improved trial designs to better assess safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Safety and Superiority of Anti-Obesity Medications. Alobaida, M., Alrumayh, A., Oguntade, AS., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

N-6 from different sources protect from metabolic alterations to obese patients: a factor analysis. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Long-chain omega-3 polyunsaturated fatty acids may be beneficial for reducing obesity-a review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The metabolic dysfunction of white adipose tissue induced in mice by a high-fat diet is abrogated by co-administration of docosahexaenoic acid and hydroxytyrosol. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Role of long-chain polyunsaturated fatty acids, eicosapentaenoic and docosahexaenoic, in the regulation of gene expression during the development of obesity: a systematic review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Prior supplementation with long chain omega-3 polyunsaturated fatty acids promotes weight loss in obese adults: a double-blinded randomised controlled trial. [2013]

6. Ireland pubmed.ncbi.nlm.nih.gov

Safety evaluation of INFAT® PLUS: Acute, genetic, teratogenic, and subchronic (90-day) toxicity studies. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Cardiovascular Safety and Superiority of Anti-Obesity Medications. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic Treatment of Obesity in Reproductive Aged Women. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of short- and long-term treatments by a low level of dietary L-carnitine on parameters related to fatty acid oxidation in Wistar rat. [2019]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Fatty acids and obesity. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Beneficial effects of l-carnitine supplementation for weight management in overweight and obese adults: An updated systematic review and dose-response meta-analysis of randomized controlled trials. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Modulation of tissue fatty acids by L-carnitine attenuates metabolic syndrome in diet-induced obese rats. [2017]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Risk assessment for carnitine. [2015]