Omega-3 Supplements for Cardiovascular Disease

(FAS Trial)

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

200 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment n-3 PUFA Supplementation for cardiovascular disease?

Research shows that omega-3 supplements, which include n-3 PUFAs, can help prevent heart problems like heart attacks and heart failure. These supplements are believed to work by reducing harmful fats in the blood and preventing irregular heartbeats and blood clots. ^{1 2 3 4 5}

Is omega-3 supplementation safe for humans?

Omega-3 supplements are generally well tolerated and cause minimal adverse effects in humans. ^{2 6 7 8 9}

How does omega-3 supplementation differ from other treatments for cardiovascular disease?

Omega-3 supplements, specifically n-3 PUFA, are unique because they work through multiple mechanisms like reducing inflammation, lowering triglycerides (a type of fat in the blood), and improving heart cell function. Unlike some other treatments, they are derived from natural sources like fish oil and can be used both for prevention and treatment of cardiovascular issues. ^{2 8 10 11 12}

What is the purpose of this trial?

The main purpose of this study is to examine whether n-3 PUFA-induced changes in metabolic risk factors are influenced by genetic variations within genes acting as fatty acids sensors.

Research Team

Marie-Claude Vohl, Ph.D.

Principal Investigator

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

Eligibility Criteria

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

Plasma triglycerides levels <4.0 mmol/L

My BMI is between 25 and 40.

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

n-3 PUFAs and cardiovascular disease prevention. [2010]

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

Polyunsaturated fatty acids and cardiovascular disease. [2019]

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

Omega-3 polyunsaturated fatty acid in primary and secondary cardiovascular disease prevention. [2009]

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

Effects of a high-dose concentrate of n-3 fatty acids or corn oil introduced early after an acute myocardial infarction on serum triacylglycerol and HDL cholesterol. [2020]

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

Omega-3 for the prevention of cardiovascular diseases: meta-analysis and trial-sequential analysis. [2023]

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

Fish oil supplementation & coronary artery disease: does it help? [2021]

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

Omega-3 Fatty Acids and Cardiovascular Disease: Are There Benefits? [2022]

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

Omega-3 polyunsaturated fatty acid supplementation in the prevention of cardiovascular disease. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A randomized clinical trial on n-3 polyunsaturated fatty acids supplementation and all-cause mortality in elderly men at high cardiovascular risk. [2013]

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

Cardiovascular Impact of Nutritional Supplementation With Omega-3 Fatty Acids: JACC Focus Seminar. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Marine n-3 fatty acids and CVD: new insights from recent follow-up studies and clinical supplementation trials. [2020]

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

Mechanisms underlying the cardioprotective effects of omega-3 polyunsaturated fatty acids. [2022]