Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in blood pressure
研究概览
简要总结
Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of the consumption of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study was followed by a second study that aimed at investigating the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30-55 years old
- •A normal blood chemistry and liver function
- •BMI < 30 kg/m2
- •previously consumed cocoa and peanut products, with no adverse reactions
排除标准
- •A history of cardiovascular disease, stroke, hypertension, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
- •Allergies to nuts, cocoa and chocolate products
- •Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or using herbal dietary supplements
研究组 & 干预措施
Cocoa Flavanol intake escalation
Ingestion of increasing number of capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process (500 mg of cocoa flavanols/capsule) during 6 weeks followed by a 2 week of washout (no capsule intake)
干预措施: Mars Cocoa Extract Capsules (Dietary Supplement)
结局指标
主要结局
Change in blood pressure
时间窗: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Blood pressure will be measured using standard techniques.
Change in platelet function
时间窗: Baseline and 14, 28, 42 and 56 days after intervention
Platelet function will be determined using the PFA-100® analyzer (Dade Behring International, Miami, FL) with collagen-epinephrine (CEPI)- and collagen-ADP (CADP) stimulation.
Change in metabolic parameters in blood
时间窗: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Metabolic parameters determined in blood included: comprehensive metabolic panel, liver panel and cell blood counting.
次要结局
- Change in plasma concentration of cocoa flavanol metabolites(Baseline (day 0) and 14, 28, 42 and 56 days after intervention)
- Change in plasma concentration of methylxanthines(Baseline (day 0) and 14, 28, 42 and 56 days after intervention)