CompletedNot Applicable

Evaluating the Effects of Omega-3 Fatty Acids on Heart Disease and Behavior

United States272 participantsStarted 2008-06

Plain-language summary

Omega-3 fatty acids are a certain kind of fish fat that has recently been shown to have health benefits. This study will examine the effectiveness of fish oil supplementation for reducing the early signs of heart disease risk and for improving mood, impulsivity, and anger levels.

Who can participate

Age range

30 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Currently employed at least 25 hours a week, but does not regularly work the third shift (i.e., night shift) * English is primary language * Consumes less than 300 mg/day of long-chain omega-3 fatty acids. Exclusion Criteria: * Serious allergy to fish (e.g., anaphylaxis, bronchospasm, serious skin reaction) * History of atherosclerotic disease (e.g., myocardial infarction) or treatment of angina or claudication (e.g., angioplasty) * Reported history of schizophrenia or bipolar disorder * Long-term hepatitis * Kidney failure * Stroke or other neurological disorder * Lung disease requiring drug treatment * Stage 2 high blood pressure, defined as systolic blood pressure of 160 mm Hg or greater and diastolic blood pressure of 100 mm Hg or greater * Alcohol consumption of more than five drinks per day each week (i.e., more than 35 alcoholic drinks each week) * Pregnant or breastfeeding * Currently taking any cardiovascular, psychotropic, glucocorticoid, lipid-lowering, insulin, or weight loss medications * Currently taking fish oil supplements

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Circulating Serum Interleukin-6 (IL-6)

Timeframe: Baseline and Month 4

C-reactive Protein (CRP)

Timeframe: baseline and month 4

Negative Affect

Timeframe: baseline and month 4

Impulsivity

Timeframe: baseline and month 4

Aggression

Timeframe: baseline and month 4

Hostility, Barefoot Score

Timeframe: baseline and month 4

Trait Anger

Timeframe: baseline and month 4

Anger Expression

Timeframe: baseline and month 4

Trial details

NCT IDNCT00663871

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2021-02-11

View on ClinicalTrials.gov More Cardiovascular Diseases trials

Who can participate

Age range

30 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Circulating Serum Interleukin-6 (IL-6)

Timeframe: Baseline and Month 4

C-reactive Protein (CRP)

Timeframe: baseline and month 4

Negative Affect

Timeframe: baseline and month 4

Impulsivity

Timeframe: baseline and month 4

Aggression

Timeframe: baseline and month 4

Hostility, Barefoot Score

Timeframe: baseline and month 4

Trait Anger

Timeframe: baseline and month 4

Anger Expression

Timeframe: baseline and month 4