Omega-3 Fatty Acids for Heart Health

Not currently recruiting at 1 trial location

Overseen By Susan Schembre, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Arizona

Must not be taking: GLP-1, Anticoagulants, Oral steroids, others

Disqualifiers: Pregnancy, Cancer, Atrial fibrillation, Psychiatric conditions, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how omega-3 supplements might improve heart health by reducing inflammation. Researchers seek to determine if different genetic backgrounds influence the effectiveness of the supplements, focusing on individuals of African and European ancestry. Participants will take either omega-3 supplements or a placebo and switch after a set period. The trial seeks healthy adults who identify as non-Hispanic African American or non-Hispanic European American and can attend regular clinic visits. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a unique opportunity to contribute to groundbreaking research.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop certain medications. The trial requires participants to refrain from using anti-inflammatory supplements, montelukast-type allergy medications, and to use acetaminophen instead of aspirin or NSAIDs. If you're on prescribed anticoagulants, oral steroids, or GLP-1, you cannot participate.

Is there any evidence suggesting that omega-3 fatty acids are likely to be safe for humans?

Research has shown that omega-3 fatty acids are generally safe for most people. Studies have found that they can improve heart health by lowering certain fats in the blood and increasing good cholesterol. These fatty acids might also reduce blood stickiness, benefiting the heart.

Omega-3 supplements are usually safe for healthy individuals. Some people have reported mild side effects, such as a fishy taste or an upset stomach, but these are uncommon. Since this trial is in its early stages, the main goal is to ensure the treatment's safety for participants. Early trials focus on safety, so researchers will closely monitor any risks during the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about omega-3 fatty acids for heart health because these compounds offer a natural alternative to traditional heart medications like statins and beta-blockers. Omega-3s are unique in that they work by reducing inflammation and lowering triglyceride levels, which can benefit heart health in a different way than typical cholesterol-lowering drugs. Additionally, being derived from fish oil, they are perceived as a more natural supplement, which may appeal to those looking for alternatives to synthetic pharmaceuticals. This novel approach could complement existing treatments, potentially leading to more comprehensive heart health strategies.

What evidence suggests that omega-3 fatty acids might be an effective treatment for heart health?

Research has shown that omega-3 fatty acids can promote heart health by lowering the risk of issues such as heart attacks. One study found that individuals who took omega-3s had a reduced risk of dying from heart disease. Another study demonstrated that consuming fish rich in omega-3s significantly lowered the risk of death from heart-related issues. Omega-3s are believed to enhance heart function and reduce inflammation. Although some studies have produced mixed results, the overall evidence supports the heart benefits of omega-3s. Participants in this trial will receive omega-3 fatty acids or a placebo in a blinded, crossover design to further evaluate their effects on heart health. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in whether omega-3 supplements can improve heart health and reduce inflammation. Participants should have different genetic backgrounds, focusing on variations in the FADS gene cluster. It's not specified who can't join, but typically those with allergies to omega-3 or serious health conditions might be excluded.

Inclusion Criteria

BMI ≥ 18.5 kg/m2

Self-identify as non-Hispanic African American or non-Hispanic European American

Willingness to refrain from intentional weight loss

Exclusion Criteria

I am currently taking oral steroids.

Allergy to the study oils

Currently pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase I

Participants receive either omega-3 supplements or placebo for 12 weeks

12 weeks

Regular visits for blood sample collection and questionnaires

Washout

Participants undergo a washout period before crossing over to the alternate treatment

4 weeks

Treatment Phase II

Participants cross over to receive the alternate treatment (omega-3 supplements or placebo) for another 12 weeks

12 weeks

Regular visits for blood sample collection and questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omega-3 Fatty Acids

Trial Overview The study tests if omega-3 fatty acids can lower inflammation markers and benefit cardiovascular health more effectively in certain genetic profiles. It's a randomized crossover trial where participants take either the supplement or placebo for a period, then switch to the other, with blood samples taken throughout.

How Is the Trial Designed?

Group I: Placebo (Group A) Experimental Treatment 2 Interventions

Participants assigned to Group A will receive one of two blinded study agents, labeled as Agent A or Agent B, during the first treatment period (Phase I), followed by a washout period, and will then cross over to receive the alternate study agent during the second treatment period (Phase II). The study agents correspond to either n-3 HUFA supplementation or placebo, but their identity remains blinded to both participants and study staff throughout the trial. Thus, Group A represents a randomized treatment sequence, and both the order of treatments and the identity of the study agents remain concealed until the study is unblinded.

Group II: Intervention (Group B) Experimental Treatment 2 Interventions

Participants assigned to Group B will receive one of two blinded study agents, labeled as Agent A or Agent B, during the first treatment period (Phase I), followed by a washout period, and will then cross over to receive the alternate study agent during the second treatment period (Phase II). The study agents correspond to either n-3 HUFA supplementation or placebo, but their identity remains blinded to both participants and study staff throughout the trial. Thus, Group B represents a randomized treatment sequence, and both the order of treatments and the identity of the study agents remain concealed until the study is unblinded.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Georgetown University

Collaborator

Trials

355

Recruited

142,000+

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. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.114.015176

Omega-3 Fatty Acids and Heart Health | Circulation In 1 study, the risk of death from coronary heart disease was 21%, 29%, 31%, and 34% lower in those who consumed fish 1 to 3 times per month, ...

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

Omega-3 Fatty Acids and Cardiovascular Disease: Effects ... Animal experiments and growing evidence in human studies suggest that n-3 PUFA consumption improves cardiac filling and myocardial efficiency. In animal ...

4. academic.oup.com academic.oup.com/eurjpc/article/31/15/1863/7692830

Effects of omega-3 fatty acids on coronary revascularization ... In the overall analysis of all trials, omega-3 supplementation reduced the risk of myocardial infarction and cardiovascular death, to a modest ...

5. jacc.org jacc.org/doi/10.1016/j.jacc.2020.11.060

Cardiovascular Impact of Nutritional Supplementation With ... Clinical trial data have shown inconsistent results with omega-3 PUFAs improving cardiovascular outcomes. In this paper, the authors provide an overview of ...

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

Omega-3 Fatty Acids - Health Professional Fact Sheet Evidence of a protective effect for omega-3 supplementation is stronger for people with existing coronary heart disease than for healthy individuals. In 2004, ...

7. thelancet.com thelancet.com/journals/eclinm/article/piis2589-5370(21)00277-7/fulltext

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 ...

8. 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 ...