Omega-3-Index Response to Eating Poultry Foods Naturally Enriched With Omega-3 Polyunsaturated Fatty Acids: A Randomized Controlled Trial in Healthy Saudi Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline in the red cell omega-3 index at 4 months
研究概览
简要总结
Diets low in seafood omega-3 polyunsaturated fatty acids (PUFAs) are very prevalent. Such diets have recently been ranked as the sixth most important dietary risk factor-1.5 million deaths and 33 million disability-adjusted life-years worldwide are attributable to this deficiency. Wild oily fish stocks are insufficient to feed the world's population, and levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in farmed fish have more than halved in the last 20 years.
The primary objective of this randomised, double-blinded, controlled nutritional trial will be to test if consumption of at least 4 servings of omega-3 PUFA-enriched chicken-meat and 4 enriched eggs per week, over a 4-month period, results in measurably higher blood levels of EPA and DHA in healthy Saudi adults.
This will be a randomised double-blind interventional study. Eighty adult male and female participants (age ≥ 18 years of age) will be asked to eat at least 4 portions of omega-3-PUFA enriched (or control) chicken-meat per week, and at least 4 omega-3-PUFA enriched (or control) eggs per week, for 4 months. Participants will be assessed at baseline and at monthly intervals for 4 months. Assessments at these visits will include; comprehensive lifestyle and medical history; food frequency questionnaire; 3 days food record; height, weight, waist and hip circumferences; blood sampling; participant well-being and adverse events. Measurement of plasma and red blood cell levels of EPA, DHA and Docosapentaenoic acid (DPA) will be performed at baseline and at study end using gas chromatography-mass spectroscopy.
The primary end point will be the change in red blood cell omega-3-index (sum of EPA and DHA expressed as percentage of total fatty acids in erythrocyte membranes) at 4 months. The nutritional trial will be analyzed on an intension to treat basis. Repeated measures ANOVA will be used to compare the two study groups. The study will be reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 statement.
详细描述
STUDY RATIONALE
In this randomized, double-blinded, controlled trial, the investigators aim to quantify the impact of regular consumption of omega-3 PUFA enriched chicken-meat and eggs over a four month period, in a healthy Saudi population.
STUDY AIMS AND OBJECTIVES.
The primary objective of this study will be to assess the red blood cell omega-3 index response of healthy Saudi adults to regular consumption of omega-3 PUFA-enriched chicken-meat and eggs. The red blood cell omega-3 index is calculated as the sum of EPA and DHA expressed as a percentage of total fatty acids in erythrocyte (red cell) membranes.
Secondary objectives include;
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, Care Provider, Investigator)
盲法说明
The randomization schedule was computer generated. Separate sealed opaque envelopes were prepared for male, female and couple participants. Participants and all investigators involved in participant recruitment, data collection and entry, sample collection, processing and analysis, will be masked to the randomization groups until data entry is completed and the database is locked.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (≥ 18 years and < 70 years)
- •Regular consumers (≥ 4 portions weekly) or willing to be regular consumers of chicken-meat.
- •Regular consumers (≥ 4 eggs weekly) or willing to be regular consumers of eggs.
- •Able to give informed consent.
排除标准
- •Concurrent or recent (within last 3 months) regular intake of long-chain omega-3-PUFA supplements (containing EPA, DPA and/or DHA).
- •Previous diagnosis of;
- •significant cardiovascular disease (e.g. myocardial infarction, coronary intervention, or stroke),
- •significant mental ill-health (e.g. major depression, psychosis or dementia) or
- •a haemoglobinopathy such as sickle cell anaemia or thalassemia .
- •Any other 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.
研究组 & 干预措施
Control Chicken-meat and Control Eggs
Consumption of at least 4 portions of standard chicken-meat and at least 4 standard eggs per week, for 4 months.
干预措施: Control poultry foods (chicken-meat and eggs) (Other)
Omega-3 Chicken-meat and Omega-3 Eggs
Consumption of at least 4 portions of omega-3-PUFA enriched chicken-meat and at least 4 omega-3-PUFA enriched eggs per week, for 4 months.
干预措施: Omega-3 polyunsaturated fatty acid, naturally enriched, poultry foods (chicken-meat and eggs) (Other)
结局指标
主要结局
Change from baseline in the red cell omega-3 index at 4 months
时间窗: 4 months (16 weeks)
The difference between the red cell omega-3 index at baseline and at 4 months. The red blood cell omega-3 index is calculated as the sum of EPA and DHA expressed as a percentage of total fatty acids in erythrocyte (red cell) membranes.
次要结局
- Change in plasma DPA(4 months (16 weeks))
- Change in red cell EPA(4 months (16 weeks))
- Change in red cell DPA(4 months (16 weeks))
- Change in plasma EPA(4 months (16 weeks))
- Change in plasma DHA(4 months (16 weeks))
- Change in red cell DHA(4 months (16 weeks))
研究者
Salwa Ali Albar
Associate Professor
King Abdulaziz University