EPA and DHA for Lipid Disorders

Overseen By Wenliang Song, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: The Miriam Hospital

Must not be taking: Aspirin, NSAIDs, Anticoagulants, Corticosteroids

Disqualifiers: Pregnancy, Malabsorption, Liver, Kidney, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how two different fish oils, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), affect people with high cholesterol. Participants will be randomly assigned to take either EPA or DHA supplements and must maintain a 28-day food and activity log. Those with high cholesterol and triglycerides, low "good" cholesterol (HDL), and who consume less than three servings of fatty fish per week might be suitable candidates. Participants will visit the clinic three times for tests and blood collection. As an Early Phase 1 trial, this research focuses on understanding how these fish oils work in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires that you do not take daily aspirin, NSAIDs (non-steroidal anti-inflammatory drugs), anticoagulants (blood thinners), or corticosteroids. If you are on these medications, you would need to stop them to participate.

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

A previous study showed that DHA (docosahexaenoic acid) is very safe. It did not affect antioxidant levels, blood clotting, or liver function. However, taking more than 3 grams a day might slow blood clotting. The amount used in this study is much lower, reducing this risk.

Research on EPA (eicosapentaenoic acid) has shown it to be well-tolerated and approved by the FDA for reducing heart disease risk. Both EPA and DHA are omega-3 fatty acids found in fish oil, which help manage cholesterol and support heart health.

Overall, both treatments are generally safe and have been used by many people. If there are concerns, consulting a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for lipid disorders focus on medications like statins that lower cholesterol by inhibiting certain liver enzymes. But DHA and EPA, the active ingredients in the trial, offer a unique approach by being omega-3 fatty acids that can help reduce triglycerides and improve overall heart health. Unlike traditional medications, these supplements are derived from fish oils and may have fewer side effects. Researchers are excited because DHA and EPA might not only lower lipid levels but also provide additional anti-inflammatory benefits, making them a promising alternative or complement to existing therapies.

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

This trial will compare the effects of DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid) on lipid disorders. Research has shown that DHA can help manage cholesterol by enlarging LDL (low-density lipoprotein) particles and improving fat processing, potentially leading to better cholesterol control for those with high levels. Additionally, DHA consistently lowers triglycerides, which are fats in the blood.

Participants in the DHA group will receive a DHA supplement regimen. Evidence suggests that EPA can lower the risk of heart problems, especially for people already taking statins (medications that lower cholesterol). High doses of EPA are particularly effective in reducing the risk of heart-related issues. Participants in the EPA group will receive an EPA supplement regimen. However, low doses of mixed omega-3s appear less effective, highlighting the importance of proper dosing to achieve the desired effects. ^{1 4 6 7 8}

Who Is on the Research Team?

Wenliang Song, MD

Principal Investigator

LIFESPAN CARDIOVASCULAR INSTITUTE

Are You a Good Fit for This Trial?

This trial is for adults with high triglycerides and cholesterol who can follow a low fatty fish diet (<3 servings per week). They must have LDL-C levels between 40-130 mg/dL, fasting TG levels of 150-500 mg/dL, and HDL-C ≤ 40 (men) or ≤ 50 (women), and be able to consent to the study.

Inclusion Criteria

I can give my consent and follow the study plan.

I agree to eat less than 3 servings of fatty fish per week.

My fasting triglycerides are between 150 and 500 mg/dL and my HDL cholesterol is low.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either EPA or DHA supplementation for 8 weeks. Various markers of thrombogenesis will be assessed.

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DHA
• EPA

Trial Overview The study tests the effects of two omega-3 fatty acids, EPA and DHA, on blood lipids and platelets in patients with lipid disorders. Participants will visit the clinic three times for checkups, tests, blood collection, and will be randomly assigned to either EPA or DHA supplements.

How Is the Trial Designed?

Group I: EPA group Experimental Treatment 1 Intervention

Participants will receive EPA supplement. 2 gelcaps, two times per day with meals (breakfast and dinner). 1 gelcap consists of 1 gram of EPA. Participants will be given 28-day food and activity log.

Group II: DHA group Experimental Treatment 1 Intervention

Participants will receive DHA supplement. 3 gelcaps, three times per day with meals (breakfast, lunch, and dinner). DHA supplement regimen contains 450 mg DHA and minimal EPA (60 mg) per pill. Participants will be given 28-day food and activity log.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10381976/

Association Between Omega‐3 Fatty Acid Intake and ... This dose–response meta‐analysis demonstrates that combined intake of omega‐3 fatty acids near linearly lowers triglyceride and non‐high‐density lipoprotein ...

2. academic.oup.com academic.oup.com/jcem/article/103/8/2909/5003412

High-Dose DHA Has More Profound Effects on LDL-Related ... The results of the present study have shown that supplementation with high-dose DHA increases LDL turnover and contributes to larger LDL particles compared ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0753332221011136

Effects of DHA dietary intervention on hepatic lipid ... Various studies have demonstrated that DHA-enriched diets displayed significant effects on relieving lipid metabolism disorders [9]. Tingting Shang et al.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10482040/

Higher docosahexaenoic acid levels lower the protective ... In contrast, DHA appears to be devoid of significant protective effects and may detrimentally impact or blunt the protection conferred by ...

5. mdpi.com mdpi.com/2072-6643/17/3/457

Lipidomics Analysis Reveals the Effects of ... This study aimed to use targeted lipidomics to evaluate the lipid composition of prefrontal-cortex (PFC) tissue in different DHA interference methods.

6. webmd.com webmd.com/vitamins/ai/ingredientmono-864/docosahexaenoic-acid-dha

Docosahexaenoic Acid (Dha) - Uses, Side Effects, and More Taking more than 3 grams daily of DHA and other omega-3 fatty acids is possibly unsafe. Doing so might slow blood clotting and increase the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522038862

LDL cholesterol–raising effect of low-dose ... A daily intake of ≈0.7 g DHA increases LDL cholesterol by 7% in middle-aged men and women. It is suggested that DHA down-regulates the expression of the LDL ...

8. jamanetwork.com jamanetwork.com/journals/jamaophthalmology/fullarticle/415641

Biological Safety Assessment of Docosahexaenoic Acid ... Docosahexaenoic acid supplementation did not compromise plasma antioxidant capacity, platelet aggregation, liver function enzyme activity, or plasma lipoprotein ...