Impacts of Omega-3-PUFA Enriched Chicken-meat and Eggs in Healthy Humans (NCT04127409) | Clinical Trial Compass
CompletedNot Applicable
Impacts of Omega-3-PUFA Enriched Chicken-meat and Eggs in Healthy Humans
Ireland160 participantsStarted 2015-02-01
Plain-language summary
Eating oily fish containing long chain seafood-derived omega-3 polyunsaturated fatty acids (PUFAs) protects against heart attacks and strokes. Hence most national and international guidelines now recommend that adults eat at least 2 servings per week of oily fish. However uptake of these recommendations is poor - many people do not eat seafood at all. A number of factors probably contribute to this poor compliance with guidelines; limited availability and costs of oily fish; distaste for oily fish; and concern about toxins in such fish. An Irish company, Devenish Nutrition, offers a possible alternative solution - by feeding omega-3 PUFA-enriched feeds to chicken, Devenish Nutrition have demonstrated that the resultant chicken meat and eggs are enriched in omega-3 PUFAs. A recently completed small study, with 30 participants, showed that 5 weeks of eating omega-3 PUFA enriched chicken resulted in increased blood levels of omega-3 PUFAs. There were also beneficial effects on blood pressure and on platelet stickiness. This study will be larger (including 160 participants) and longer in duration (6 months). It will be a double-blind, controlled, randomized study. This will allow testing whether eating omega-3 PUFA enriched chicken-meat regularly over a 6 month period, results in even greater increments in blood levels of omega-3 PUFAs, and in greater beneficial effects on cardiovascular risk factors. Beneficial effects of eating omega-3 PUFA enriched eggs will also be assessed.
Who can participate
Age range
18 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:
* Adults (≥ 18 years)
* Able to give informed consent
Exclusion Criteria:
* Previous diagnosis of significant cardiovascular disease (myocardial infarction, coronary intervention, or stroke).
* Currently prescribed anti-hypertensive, lipid lowering, anti-platelet therapy or non-steroidal anti-inflammatory drugs.
* Discovery of sustained hypertension (Daytime BP average \> 140/90), and/or significant dyslipidaemia (Fasting LDL Cholesterol \> 4mmol/l or Triglycerides \> 4mmol/) at the baseline assessments.
* Currently regularly taking Omega-3 PUFA supplements.
* Any known, unresolved history of drug use or alcohol dependency, lack of ability to comprehend or follow instructions, or unlikely or unable to comply with study follow-up requirements
* Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
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.