Postprandial Effects of Polyphenol-rich Cocoa Beverage on Glucose, Insulin, Lipids, Oxidative Stress and Inflammation in Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Blood pressure (mm Hg)
研究概览
简要总结
This study aims to investigate the postprandial effects of cocoa supplementation in glucose and lipids, and surrogate markers of atherosclerosis in patients with type 2 diabetes. The investigators aim to test the hypothesis that cocoa will lower high-fat mixed meal breakfast-induced postprandial rise of glucose, lipids and markers of atherosclerosis in patients with diabetes. Randomized cross-over controlled trial, in which participants will be assigned to the placebo or cocoa group with breakfast meal. Patients with type 2 diabetes(n=25) will qualify for the study. The participants will be asked to consume 2 cups cocoa or placebo beverage on 2 separate postprandial study days. Both groups will receive high-fat mixed meal breakfast on each day. Blood draws and blood pressure (including HDI) measurements will be conducted at fasting, 30 min, 1,2, 4 & 6 hours postprandial each day for 2 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •clinical diagnosis of type 2diabetes
排除标准
- •on insulin therapy
研究组 & 干预措施
Cocoa
Cocoa polyphenols (960mg)
干预措施: Cocoa polyphenols (Dietary Supplement)
Placebo
Placebo powder (109mg polyphenols) in water
干预措施: Cocoa polyphenols (Dietary Supplement)
结局指标
主要结局
Blood pressure (mm Hg)
时间窗: 2.5 years
Change in blood pressure and vascular function following cocoa and placebo intervention
次要结局
- Blood lipids(2.5 years)
- Inflammation(2.5 years)
- Glucose (mg/dL)(2.5 years)
研究者
Arpita Basu
Associate Professor
Oklahoma State University
