A Study of the Absorption, Distribution and Cardiovascular Benefits for Humans of Eating Chicken-meat and Eggs Enriched With Omega-3 PUFAs Over a 6-month Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Red Cell Omega-3 Index
研究概览
简要总结
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.
详细描述
BACKGROUND
There are four long chain omega-3 polyunsaturated fatty acids (PUFAs). Alpha-linolenic acid (ALA 18:3n-3) is found in plants. However the remaining three omega-3 PUFAs, which are longer and more unsaturated (Eicosapentaenoic acid, EPA 20:5n-3, Docosapentaenoic acid, DPA 22:5n-3, and Docosahexaenoic acid, DHA 22:6n-3), are in large part found in oily seafood
Consumption of oily fish, and of long chain seafood-derived omega-3 polyunsaturated fatty acids (PUFAs), has been strongly and consistently associated with reduced cardiovascular morbidity and mortality. In a 2011 "State of the Art Paper" Mozaffarian and colleagues concluded that "current data provide strong concordant evidence that long chain (seafood) n-3 PUFA are bioactive compounds that reduce risk of cardiac death".
Seafood derived omega-3 PUFAs influence a myriad of molecular pathways including membrane structure, ion channel properties, genetic regulation, hepatic fatty acid metabolism, eicosanoid and inflammatory mediator synthesis. It appears likely that the beneficial effects of omega-3 PUFAs are mediated through downstream effects on a range of cardiovascular risk factors including blood pressure, heart rhythm, lipid levels, inflammation, and lastly thrombotic tendency through effects on platelet function. The omega-3 fatty acid docosahexaenoic acid (DHA) is proven essential to pre and postnatal brain development while eicosapentaenoic acid (EPA) is more influential on behaviour and mood.
Because of the strong evidence of benefits of seafood derived omega-3 PUFAs, most national and international guidelines now recommend that adults eat at least 2 servings/week of oily fish (>250 mg/day of long-chain omega-3 PUFAs). However uptake of these recommendations is poor - many people do not consume seafood at all, and approximately one-half of U.S adults consume <60 mg/day of EPA+DHA. A number of factors probably contribute to this poor compliance; limited availability and costs of oily fish; distaste for oily fish; and concern about toxins in such fish including methylmercury, polychlorinated biphenyls and dioxins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomisation and masking The randomisation schedule was computer generated. Separate sealed opaque envelopes were prepared for male and female participants. All investigators involved in participant recruitment, data collection and entry, sample collection, processing and analysis, will be masked to the randomisation groups until data entry is completed and the database is locked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (≥ 18 years)
- •Able to give informed consent
排除标准
- •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.
结局指标
主要结局
Red Cell Omega-3 Index
时间窗: 6 months
Sum of EPA and DHA expressed as percentage of total fatty acids in erythrocyte membranes
次要结局
- Mood(6 months)
- Heart rate(3 and 6 months)
- Thrombotic tendency 2(3 and 6 months)
- Information Processing Speed(6 months)
- Systolic blood pressure(3 and 6 months)
- Global cognition(6 months)
- Visual Memory(6 months)
- Plasma levels of EPA and DHA(3 and 6 months)
- Thrombotic tendency 1(3 and 6 months)
- Red Cell Omega-3 Index(3 months)
- Inflammation(3 and 6 months)
- Executive Function(6 months)
- Verbal Memory(6 months)
- Psychomotor Speed(6 months)
- Diastolic blood pressure(3 and 6 months)
研究者
Alice Stanton
Professor of Cardiovascular Therapeutics
Royal College of Surgeons, Ireland