NUTS for the Prevention of Cardiovascular Disease in Chinese Adults : a Randomized Controlled Trial (NUTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Post-intervention differences in blood plasma alpha linolenic acid between groups
研究概览
简要总结
This study evaluates the feasibility of walnuts supplementation among population of high CVD risks over a period of 6 months. 70 participants will be controls receiving non-edible gifts. 70 participants will be given 30 grams of walnuts everyday and 70 participants will be given 60 grams of walnuts a day.
详细描述
Increased consumption of nuts improves the levels of lipid risk factors associated with cardiovascular disease and consistently relates to lower risk of cardiovascular disease (CVD) in prospective cohort studies. The estimates of health effects and potential population benefits of increased consumption of nuts are based mostly on observational data and there remains considerable uncertainty about whether higher intake of nuts will actually reduce cardiovascular outcomes. To address this uncertainty will require a well-conducted, adequately powered, large-scale, randomised control trial that tests the causal relationship between nut intake and the risk of cardiovascular diseases.
We hereby designed a 6-month walnut supplementation trial in a rural area of China with high rates of CVD, to obtain data to support and help to refine the design of a future long-term large RCT testing the effect of nut supplementation on CVD risk. The main objectives of the current trial are to assess the acceptability and adherence to two different doses of walnut supplementation (30 and 60 grams per day). The exploratory objectives are to determine the effects of walnut supplementation on cardiovascular risk factors including blood lipids, fasting glucose, and body weight.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
This study is a single-blinded trial where investigators and outcome assessors will be blinded to the groups the participants are randomized to.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of CVD, defined on the basis of a prior hospitalisation for a myocardial infarction or stroke, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (with or without stenting), peripheral revascularization (angioplasty or surgery), symptomatic with documented hemodynamically-significant carotid or peripheral vascular disease, or amputation secondary to vascular disease, OR
- •Male aged >60 years, or female aged>65 years, AND
- •With at least two of the following risk factors:
- •Type 2 diabetes requiring treatment with at least two oral anti-hyperglycaemic agents and/or insulin
- •Systolic blood pressure > 140 mmHg while on one or more antihypertensive agents
- •Current daily smoking
- •Dyslipidaemia defined as HDL-cholesterol<1.0mmol/L or LDL-cholesterol>6.0mmol/L
- •Micro or macro albuminuria
排除标准
- •Allergic to nuts (history of food allergy with hypersensitivity to any of the components of nuts)
- •Other serious medical condition that prevents nut consumption (e.g. digestive disease with fat intolerance)
- •Any medical condition thought to limit survival to less than 1 year
- •Difficulty with consuming nuts (e.g. dental health issues that prevent chewing walnuts)
- •Unwilling to consume nuts
结局指标
主要结局
Post-intervention differences in blood plasma alpha linolenic acid between groups
时间窗: From baseline to 6 months
Blood plasma alpha linolenic acid will be measured at baseline and 6 months (end of trial).
次要结局
- Post-intervention differences in estimated dietary nuts intake from 24h dietary recall between groups(From baseline to 6 months)
- Differences in adherence and acceptability of walnuts between the high and low dose groups(From 2 week, 12 weeks to 6 months)