Effects of Hazelnuts and Cocoa on Metabolic Parameters and Vascular Reactivity in Healthy Subjects: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Effects of a breakfast integration on vascular reactivity, assessed by the variation of peak systolic velocity of the brachial artery, in healthy subjects.
研究概览
简要总结
This study aims to assess the effects of hazelnuts, cocoa, and the combination of both on vascular reactivity and metabolic profile. Participants, divided in six groups, will receive one of these breakfast integrations for 14 days:
group 1) 30 g peeled hazelnuts;
group 2) 30 g unpeeled hazelnuts;
group 3) snack with 30 g peeled hazelnuts;
group 4) snack with 2.5 g cocoa powder;
group 5) snack with 30 g peeled hazelnuts and 2.5 g cocoa;
group 6) empty snack, control group.
详细描述
In the last few years, the prevalence of overweight and obesity has increased in all age groups. The European Food Safety Authority stated "cocoa flavanols help maintain endothelium-dependent vasodilation, which contributes to normal blood flow". Several studies reported that a daily consumption of hazelnuts reduces the risk of cardiovascular disease. The hypothesis of this study is to demonstrate a beneficial effect of hazelnut and cocoa diet integrations on vascular reactivity and endocrine-metabolic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5-24.9 kg/m2
排除标准
- •diabetes mellitus
- •glucose intolerance
- •dyslipidemia
- •metabolic syndrome
- •allergies
结局指标
主要结局
Effects of a breakfast integration on vascular reactivity, assessed by the variation of peak systolic velocity of the brachial artery, in healthy subjects.
时间窗: 2 weeks
Vascular reactivity is measured by assessing the peak systolic velocity (PSV in cm/s) of the brachial artery at rest and after 3 minutes of arterial occlusion using an echographer in Doppler mode. To occlude arterial inflow, a sphygmomanometric cuff is placed above the antecubital fossa and inflated to at least 50 mmHg above systolic pressure for 3 minutes.
次要结局
- Effects of a breakfast integration on glucagon (pg/mL) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on ghrelin (ng/mL) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on low-density lipoprotein-cholesterol (mg/dL) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on triglycerides (mg/dL) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on high-density lipoprotein-cholesterol (mg/dL) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on total cholesterol (mg/dL) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on insulin (uU/mL) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on homocysteine (umol/L) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on glucose (mg/dL) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on leptin (ng/mL) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on uric acid (mg/dL) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on ESR (mm/h) in healthy subjects.(2 weeks)
- Effects of a breakfast integration on hs-CRP (mg/dL) in healthy subjects.(2 weeks)