The Effects of the Substitution of Dietary SFA With n-6 PUFA or MUFA on Vascular Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 4
- 主要终点
- Percent Change in Flow Mediated Dilatation (FMD)
研究概览
简要总结
It is well established that diet plays an important role in both the development and progression of heart disease. Different types of dietary fat have varying effects on heart disease risk factors. The elasticity of an individual's blood vessels is strongly associated with heart disease risk and recent evidence suggests that dietary manipulation may influence elasticity of the blood vessels with dietary fat (including saturated, monounsaturated and polyunsaturated fatty acids) as a potentially important modulator. Substantial evidence exists on the effects of monounsaturated fats (type of fatty acids mainly found in olive and rapeseed oil), n-6 polyunsaturated fats (type of polyunsaturated fatty acids found in vegetable oils) and saturated fat (found mainly in animal derived products) on lipid levels. However, the influence of these dietary fats on the elasticity of blood vessels remains unclear.The main purpose of the DIVAS study is to determine the effects of the substitution of saturated fats with either n-6 polyunsaturated or monounsaturated fats on blood vessel elasticity and to determine the effects of these different dietary fats on other risk factors for heart disease including lipoproteins and inflammatory biomarkers.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults should have a relative risk (RR) of > 1.5 of developing cardiovascular disease (CVD) based on presenting with at least one recognised risk factor for CVD:
- •total cholesterol (TC) > 6.0 mmol/l
- •HDL cholesterol (HDLC) ≤ 1.0 mmol/l male, ≤ 1.3 mmol/l female
- •Glucose ≥ 6 mmol/l
- •Stage 1 hypertension or above i.e. a systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg
- •BMI 28-35 kg/m2
- •waist >102 cm male or > 84 cm female
- •Adults with a first degree relative with either a history of premature CVD - age of onset younger than 55 y in fathers, sons or brothers or younger than 65 y in mothers, daughters or sisters, or type 2 diabetes.
排除标准
- •having suffered a myocardial infarction/stroke in the past 12 months
- •diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders
- •suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
- •on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- •no history of alcohol abuse
- •planning or on a weight reducing regime
- •taking any fish oil, fatty acid or vitamin and mineral supplements
- •pregnant, lactating or planning a pregnancy
结局指标
主要结局
Percent Change in Flow Mediated Dilatation (FMD)
时间窗: Baseline, 4 months
次要结局
- 24-hour Ambulatory Blood Pressure(4 months)
- Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP)(4 months)
- Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells)(4 months)
- Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)(4 months)
研究者
Julie Lovegrove
Professor
University of Reading