Effects of Polyphenolic-rich Dark Chocolate/Cocoa and Almonds on Cardiovascular Disease Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Flow-mediated dilation change
研究概览
简要总结
The purpose of this study is to investigate the individual and combined effects of dark chocolate/cocoa and almonds on lipids, lipoproteins, antioxidant defense, lipid peroxidation, phenolic acids, inflammatory status, blood pressure and arterial health. It is hypothesized that dark chocolate/cocoa and/or almonds will favorably affect lipids, lipoproteins, antioxidants, inflammatory status, blood pressure and arterial health compared to a healthy American control diet; however, the effects will be greater when dark chocolate/cocoa and almonds are consumed together versus consumption of each food individually.
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 (Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight and obese (BMI ≥25, ≤40 kg/m2)
- •Moderately elevated LDL-C between the 25-95th percentile from NHANES:
- •105-194 mg/dL for males; 98-190 mg/dL for females.
排除标准
- •Tobacco use
- •Systolic blood pressure ≥159 mm Hg
- •Diastolic blood pressure ≥ 99 mm Hg
- •A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on meds)
- •Blood pressure or cholesterol-lowering medication use
- •Refusal to discontinue intake of putative cholesterol-lowering supplements (e.g. psyllium, fish oil, soy lecithin, niacin, fiber, flax, stanols/sterols)
- •Vegetarianism or dietary practices that are inconsistent with the test diets
- •Nut allergies
- •Refusal to discontinue nutritional supplements, herbs, or vitamins
- •History of inflammatory gastrointestinal disease
结局指标
主要结局
Flow-mediated dilation change
时间窗: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Lipid/lipoprotein change (standard panel)
时间窗: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
24-hour ambulatory blood pressure change
时间窗: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
Lipoprotein class and subclass change
时间窗: 0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods)
The VAP© Test provides a direct measure of the following lipid and lipoprotein classes and subclasses: LDL, Lp(a), IDL, LDL1, LDL2, LDL3, LDL4, HDL, HDL2, HDL3, VLDL, VLDL1+2, VLDL3, TC, TG, Non-HDL, Remnant Lipoproteins, ApoB100, and ApoA1.
次要结局
- Serum C-reactive protein change(0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods))
- Plasma flavonoid change(0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods))
- LDL oxidation potential change (plasma)(0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods))
- Serum insulin change(0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods))
- Serum glucose change(0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods))
- Urinary F2α-isoprostane change(0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods))
- Plasma tocopherol change(0 wk, 4 wk, 10 wk, 16 wk, and 22 wk (at baseline and after each of the 4 diet periods))