Effects of Cocoa on Ambulatory Blood Pressure and Vascular Function in Patients With Stage I Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Office Blood Pressure
研究概览
简要总结
The proposed study Dose And Response to Cocoa (DARC), will examine variation in dose of cocoa-containing product consumption over an 8-week period and assess effects on blood pressure, endothelial function and arterial stiffness. The randomized, controlled, modified Latin square parallel design will compare the effects of two doses of cocoa consumption on blood pressure, endothelial function and arterial stiffness in 120 adults with stage 1 hypertension.
详细描述
Hypothesis #1 To verify the efficacy of an 8-week course of cocoa-containing product consumption on blood pressure in adults with stage 1 hypertension. Specifically, to demonstrate at least 3.5 mmHg improvement in 24-hour mean systolic blood pressure following 8 weeks of treatment with cocoa- containing products when compared to placebo. Our hypothesis is that cocoa-containing product consumption will result in clinically significant improvement of systolic blood pressure at the conclusion of an 8-week course of treatment.
Hypothesis #2 To identify a dose-response relationship in which increasingly higher doses of cocoa powder in cocoa-containing products will demonstrate correspondingly greater beneficial effects on blood pressure over an 8-week period in individuals with stage 1 hypertension. Specifically, to investigate the effects of the variation of dose of cocoa powder in cocoa-containing products (i.e. 5 grams or 10 grams of cocoa powder) for 8 weeks on blood pressure. We hypothesize that increasingly higher doses of cocoa powder in cocoa-containing products will demonstrate correspondingly greater beneficial effects on blood pressure.
Hypothesis #3 To assess the effects of different doses of cocoa-containing product consumption over an 8-week period on 24-hour diastolic blood pressure, endothelial function, arterial stiffness, serum lipids, theobromine, CRP, glucose, insulin, body weight, and waist circumference in adults with stage 1 hypertension. We hypothesize that consumption of cocoa-containing products will lower diastolic blood pressure; improve endothelial function of our participants; reduce arterial stiffness; improve serum lipids; theobromine; and will have no clinically meaningful effects on body weight and waist circumference, CRP, glucose, or insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women age 18-75 years
- •stage 1 hypertension (i.e. 140-159/90-99 mmHg) without anti-hypertensive medication or with only one anti-hypertensive medicaion
- •body mass index < 35 kg/m²
- •willing to discontinue the use of chocolate/cocoa products at least 4 weeks prior to intervention.
排除标准
- •anticipated inability to complete or comply with study protocol
- •use of lipid-lowering or aspirin unless stable on medication for at least 1 month and willing to refrain from taking medication for 12 hours prior to endothelial function scanning
- •severe hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100 mmHg), or use more than one anti-hypertensive medications
- •allergic to cocoa products (chocolate or cocoa powder)
- •regular use of vitamin C, vitamin E, fish oil, flax seed oil, omega-3 fatty acids, Coenzyme Q10, fiber supplements, garlic pills, arginine, red yeast rice, and/or any kind of antioxidant and unwilling to discontinue supplementation for at least 4 weeks prior to study initiation and for the study duration. Use of a multi-vitamin containing no more than two times the recommended daily allowance for vitamins C and E is permissible
- •diagnosed eating disorder
- •on any specific diet, weight control diet, and/or vegan diet
- •substance abuse (chronic alcoholism and/or other chemical dependency)
- •any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., cancer, AIDS, tuberculosis, psychotic disorder)
- •current or impending pregnancy. In premenopausal women, pregnancy will be excluded by pregnancy test at the time of each study visit.
结局指标
主要结局
Office Blood Pressure
时间窗: 8 Weeks
Systolic and diastolic BP will be measured at each visit using an approved automated device. Blood pressure will be measured (average of three measurements with five minutes between measurements) with the participant sitting in a quiet room.
Ambulatory Blood Pressure Monitoring (ABPM)
时间窗: 8 weeks
Subjects will undergo 24-hour ambulatory blood pressure monitoring using a FDA approved device (Model 90207 with standard adult cuff or large cuff (depending on arm size), Spacelabs Medical, Inc.). BP will be measured every 30 minutes throughout the 24-hour monitoring period. Mean systolic, mean diastolic, and average mean blood pressure will be calculated from all valid BP measurements. Daytime and nighttime (11:00 PM till 6:30 AM) BP will also be assessed.
次要结局
- Central Aortic Stiffness(8 Weeks)
- Fasting Serum Lipids(8 Weeks)
- C-Reactive Protein (CRP)(8 Weeks)
- Body Weight(8 Weeks)
- Flow-mediated dilatation (FMD)(8 Weeks)
- Fasting Glucose and Insulin(8 Weeks)
- Physical Activity(8 Weeks)
- 3- Day Food Diary(8 Weeks)
- Waist Circumference(8 Weeks)