Investigation Into Incorporation of (n-3) Polyunsaturated Fatty Acids Into Erythrocyte Membranes and Clearance, and Effects on Platelet Function, Arterial Function and Endothelial Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Platelet Monocyte Aggregates (PMA)
研究概览
简要总结
The purpose of this study was to determine whether supplementation with oils enriched with long chain n-3 PUFA, either EPA or DHA, had a differential effect on platelet, endothelial and vascular function.
详细描述
Relatively few studies have made a head-to-head comparison of DHA (22:6n-3) with EPA (20:5n-3). The understanding of this differential effect may be of great interest in populations with low EPA intake such as vegetarians, who may choose to supplement their dietary intake of long-chain n-3 PUFA in the form of DHA-rich algal oil.
This study aimed to investigate the effect of supplementation with oils rich in either EPA or DHA (3g/day, 6 weeks) in healthy young males on platelet, endothelial and vascular function, as well as other CVD risk factors. The primary outcomes were platelet monocyte aggregates and endothelial progenitor cells - novel markers of platelet and endothelial function, measured by flow cytometry, Secondary outcomes included capillary density, measured by capillaroscopy to assess changes in microvascular function, pulse wave analysis, digital volume pulse and ambulatory blood pressure. Other secondary outcomes included lipid profiles (TAG, cholesterol, NEFA), glycaemic control (HOMA, QUICKI) and oxidative stress (isoprostane). The omega-3 index (erythrocyte EPA+DHA) was used as a marker of compliance.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •No smokers
- •Aged 18-45y old
- •Able to understand the information sheet and comply with all the trial procedures
- •Having given written consent to take part in the study prior to participation.
排除标准
- •Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke, dyslipidemia), diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
- •Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
- •Current smokers; history of substance abuse or alcoholism (previous weekly alcohol intake >60 units/week); current self-reported weekly alcohol intake exceeding 28 units
- •Recent use of hypolipidaemic, antihypertensive, antiplatelet or antithrombotic mediations
- •Platelet count above or below the normal range or any history indicative of a congenital or acquired platelet or haemostatic defect.
- •Allergy or intolerance to any component of study capsules
- •Unwilling to restrict consumption of any source of fish oil for the length of the study
- •Subjects reporting consumption of >1 portion oily fish per week
- •Weight change of >3 kg in preceding 2 months; BMI <18 and >32 kg/m2
- •Blood pressure>160/90 mmHg
- •Fasting blood cholesterol > 6.5 mmol/L; fasting triacylglycerol concentrations > 2.0 mmol/L
研究组 & 干预措施
Olive oil (BP specification)
5g per day
干预措施: Placebo - olive oil (BP specification) (Dietary Supplement)
DHA-rich oil
Fish oil supplement (total = 5g/day) providing 3.1g/day of DHA triacylglycerol, blended with olive oil
干预措施: DHA-rich triacylglycerol oil (Dietary Supplement)
EPA-rich oil
Fish oil supplement (total = 5g/day) providing 2.9g/day of EPA triacylglycerol, blended with olive oil
干预措施: EPA-rich triacylglycerol oil (Dietary Supplement)
结局指标
主要结局
Platelet Monocyte Aggregates (PMA)
时间窗: 6 weeks
The endothelium plays a vital role in the regulation of blood flow, thrombosis and inflammation. Endothelium-derived anti-adhesive and anti-aggregant substances, including prostacyclin and nitric oxide, are known to inhibit platelet activation. Endothelial dysfunction or vessel wall injury lead to the activation of platelets, of which platelet-monocyte-aggregates (PMA) are a sensitive marker, and were shown to inversely correlate with markers of EF in patients with stable CHD. The measurement of PMA by flow cytometry is a method which reduces ex vivo platelet activation to its minimum and is believed to represent platelet activation in vivo.
Endothelial Progenitor Cell (EPC) counts
时间窗: 6 weeks
EPCs are a subgroup of circulating progenitor cells that are recruited from the bone marrow to repair the injured vasculature. They have been associated with a reduced CVD risk and may serve as markers of endothelial function because they represent a greater capacity for the endothelium to repair itself. Two populations of EPCs were measured by flow cytometry, described as 'early EPC' (KDR+/CD34+/CD133+) and 'late EPCs' (KDR+/CD34+/CD31+).
次要结局
- Serum total cholesterol concentration(6 weeks)
- Serum high density lipoprotein concentration(6 weeks)
- Arterial stiffness(6 weeks)
- Blood Pressure (BP) and Heart Rate (HR)(6 weeks)
- Plasma Nitrate and Nitrites (NOx) concentrations(6 weeks)
- Serum Triacylglycerol concentrations(6 weeks)
- Serum non esterified fatty acids (NEFA) concentration(6 weeks)
- Serum Apolipoprotein B concentration(6 weeks)
- Plasma glucose concentration(6 weeks)
- Serum resistin concentration(6 weeks)
- Fatty acid profile of plasma non esterified fatty acid fraction(6 weeks)
- Capillary density(6 weeks)
- Plasma isoprostane concentrations(6 weeks)
- Serum low density lipoprotein concentration(6 weeks)
- Plasma insulin concentration(6 weeks)
- Erythrocyte phospholipid fatty acid profiles(6 weeks)
- Serum adiponectin concentration(6 weeks)
研究者
Dr Wendy Hall
Lecturer in Nutritional Sciences
King's College London