Fatty Acid + L-Carnitine for Obesity

Overseen By John R Koethe, MD

Age: 18+

Sex: Male

Trial Phase: Academic

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

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?

This trial explores new methods to assist Veterans with HIV who experience myosteatosis, a specific type of obesity affecting muscles that can lead to serious health issues. Researchers are testing various combinations of a healthy diet with supplements like omega-3 fatty acids (a type of healthy fat) and L-carnitine (a supplement that helps the body produce energy), some combined with exercise, to determine the most effective approach. The trial is open to Veterans with HIV who are on certain HIV medications and have a body mass index (BMI) between 28 and 50. As an unphased trial, it offers Veterans a unique opportunity to contribute to innovative research that could improve health outcomes.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that omega-3 fatty acids are generally safe and can help reduce inflammation and support heart health. They may also improve fat processing and blood flow, potentially aiding in weight control. Studies have not found strong evidence of major side effects from omega-3 supplements.

L-carnitine is another supplement studied for weight loss. Research found that people taking L-carnitine lost more weight than those who took a placebo. Studies also show that L-carnitine is safe, even at higher doses, with no significant side effects reported when taking up to 6 grams daily for a year.

When used together, omega-3s and L-carnitine may further enhance fat metabolism. Overall, both treatments appear safe based on current research. However, consulting healthcare professionals is advisable for any concerns about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for obesity because they combine natural supplements to potentially enhance weight loss. L-carnitine is unique as it helps the body convert fat into energy, a process not typically targeted by standard pharmaceutical options like orlistat or phentermine. Omega-3 fatty acids, known for their anti-inflammatory properties, may also improve metabolic health, offering a different approach compared to traditional treatments. Together, these supplements could provide a complementary strategy to current medications, addressing obesity through both metabolic and energy-utilization pathways.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that omega-3 fatty acids, which participants in this trial may receive, can help reduce body fat in people with obesity by increasing fat burning and decreasing fat storage. Studies have also found that L-carnitine supplements, another treatment option in this trial, can aid weight loss by lowering body weight and fat. One trial arm tested the combination of omega-3 fatty acids and L-carnitine, which might enhance these effects by improving blood flow and reducing hunger. This combination could be a promising way to manage obesity. ^{2 3 5 6 7}

Who Is on the Research Team?

John R Koethe, MD

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Heidi J Silver, PhD

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32359762/

Effects of l-carnitine supplementation on weight loss and ... Conclusions: l-carnitine supplementation provides a modest reducing effect on body weight, BMI and fat mass, especially among adults with overweight/obesity.

2. imrpress.com imrpress.com/journal/IJVNR/95/2/10.31083/IJVNR40033/htm

The Effect of the L-Carnitine Supplementation on Obesity ... The findings of this umbrella meta-analysis support that supplementation of L-carnitine supplementation can successfully manage weight, BMI, and WC reduction.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1043661819315117

Beneficial effects of l-carnitine supplementation for weight ... Meta-analysis results revealed that l-carnitine supplementation significantly decreased weight (WMD: −1.129 kg, 95 % CI: −1.590, −0.669; I2: 63.4), body mass ...

4. jissn.biomedcentral.com jissn.biomedcentral.com/articles/10.1186/s12970-020-00377-2

The bright and the dark sides of L-carnitine supplementation Pooled results demonstrated a significant reduction in weight following LC supplementation, but the subgroups analysis revealed no significant ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31743774/

Beneficial effects of l-carnitine supplementation for weight ... L-carnitine significantly decreased weight, BMI, and fat mass, especially in overweight/obese subjects, but not body fat percentage or waist circumference.

6. ods.od.nih.gov ods.od.nih.gov/factsheets/Carnitine-HealthProfessional/

Carnitine - Health Professional Fact Sheet Study participants who took carnitine supplements lost an average of 1.33 kg more weight than those who took a placebo, regardless of the study ...

7. healthline.com healthline.com/nutrition/l-carnitine

L-Carnitine: Benefits, Side Effects, Sources, and Dosage A 2019 reviewTrusted Source found that L-carnitine significantly reduced diastolic blood pressure, especially in people with overweight and ...