Omega-3 Supplements for Cardiovascular Disease

(FAS Trial)

Not currently recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Anticoagulants, n-3 PUFA

Disqualifiers: Diabetes, Hypertension, Severe dyslipidemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether omega-3 supplements can alter certain genetic risk factors for heart disease. Participants will take omega-3 supplements, known for their heart benefits, to assess their impact on these risk factors. The study seeks healthy individuals with a BMI (body mass index, a measure of body fat based on height and weight) between 25 and 40, who do not have serious health conditions like diabetes or heart disease. As an unphased trial, it offers participants the chance to contribute to significant genetic research that could lead to personalized heart health strategies.

Will I have to stop taking my current medications?

If you are taking medication for high cholesterol, high blood pressure, diabetes, or blood thinners, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that n-3 PUFA supplementation is likely to be safe for humans?

Research shows that omega-3 supplements, which contain a type of healthy fat, are generally safe. Studies have found that they can reduce the risk of heart issues, such as heart attacks and other heart diseases. People usually tolerate these supplements well, and major reports of serious side effects are absent from the available data. While often used for heart health, omega-3s are also under investigation for other benefits. Overall, omega-3 supplements appear safe and beneficial for heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cardiovascular disease, which often include medications like statins and beta-blockers that primarily focus on lowering cholesterol and blood pressure, omega-3 supplements offer a unique approach by targeting inflammation and triglyceride levels. Researchers are excited about omega-3s, particularly the combination of EPA and DHA, because they have the potential to improve heart health through their anti-inflammatory properties and ability to reduce triglycerides. This natural supplementation could provide a complementary or alternative option for those who either cannot tolerate traditional medications or who are looking for additional cardiovascular benefits.

What evidence suggests that n-3 PUFA supplementation might be an effective treatment for cardiovascular disease?

Studies have shown that omega-3 fatty acids can lower the risk of serious heart issues. One study found that omega-3s were linked to a 6% lower risk of major heart events and fewer deaths from heart problems. Another study suggested that omega-3s can reduce deaths related to heart disease and improve heart health. They also help reduce blood clotting and may slightly improve cholesterol levels. However, some research did not find omega-3s effective in preventing heart issues or death. Overall, omega-3 supplements have shown promise, but results can vary. This trial will provide participants with omega-3 supplementation to further evaluate its effects on cardiovascular health. ^{3 6 7 8 9}

Who Is on the Research Team?

Marie-Claude Vohl, Ph.D.

Principal Investigator

Institute of Nutraceutical and Functional Foods (INAF), Laval University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-50 with a BMI of 25-40kg/m2 and normal triglyceride levels. Participants should not smoke, drink alcohol regularly, or have thyroid/metabolic disorders like diabetes or severe dyslipidemia. Pregnant/nursing women and those on certain medications are excluded.

Inclusion Criteria

My BMI is between 25 and 40.

I do not have diabetes, high blood pressure, severe cholesterol issues, or heart disease.

Plasma triglycerides levels <4.0 mmol/L

Exclusion Criteria

I am on medication for high cholesterol, high blood pressure, diabetes, or I take blood thinners or omega-3 supplements.

Body mass index > 40kg/m2

Pregnant or nursing women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive omega-3 supplementation (3g EPA+DHA/d) to assess metabolic risk factor response

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• n-3 PUFA Supplementation

Trial Overview The study is testing the effects of n-3 PUFA (Omega-3 fatty acid) supplements on metabolic risk factors related to cardiovascular disease, considering genetic variations that might affect how individuals respond to these fats.

How Is the Trial Designed?

Group I: capsules omega-3 Experimental Treatment 1 Intervention

Omega-3 supplementation (3g EPA+DHA/d)

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8413259/

Effect of omega-3 fatty acids on cardiovascular outcomes Omega-3 FAs reduced cardiovascular mortality and improved cardiovascular outcomes. The cardiovascular risk reduction was more prominent with EPA monotherapy ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9333496/

Effects of omega-3 fatty acid on major cardiovascular ... Omega-3 fatty acid was noted to be associated with a lower risk of major cardiovascular events (RR, 0.94; 95% CI, 0.89–1.00; P = .049) and cardiac death.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622028632

(n-3) Fatty Acids and Cardiovascular Health: Are Effects of ... All three (n-3) PUFA reduce ex vivo platelet aggregation and DHA also modestly increases LDL and HDL particle size; the clinical relevance of such findings is ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1203859

n–3 Fatty Acids and Cardiovascular Outcomes in Patients ... In this study, we found that a daily 1-g dose of n–3 fatty acids, as compared with placebo, did not prevent death or any cardiovascular outcomes ...

5. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000000482

Omega-3 Polyunsaturated Fatty Acid (Fish Oil) ... To date, no published RCTs have assessed the effect of omega-3 PUFA supplements on the primary prevention of heart failure. On this basis, no ...

6. ods.od.nih.gov ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/

Omega-3 Fatty Acids - Health Professional Fact Sheet Supplement users also had significant reductions in rates of fatal myocardial infarction, total coronary heart disease, and percutaneous coronary intervention ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3278271/

(n-3) Fatty Acids and Cardiovascular Health: Are Effects of ... Combined EPA+DHA or DPA+DHA levels are associated with lower risk of fatal cardiac events and DHA with lower risk of atrial fibrillation, suggesting direct or ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0735109711031317

Omega-3 Fatty Acids and Cardiovascular Disease: Effects ... Overall, current data provide strong concordant evidence that n-3 PUFA are bioactive compounds that reduce risk of cardiac death. National and international ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa1811403

Marine n−3 Fatty Acids and Prevention of Cardiovascular ... Higher intake of marine n−3 (also called omega-3) fatty acids has been associated with reduced risks of cardiovascular disease and cancer in several ...