The Effect of Bioactives in Dried Plums, Figs, Dates, and Raisins Compared With a High Carbohydrate Snack on Risk Factors for Cardiometabolic Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- LDL Cholesterol
研究概览
简要总结
This is a 2-period randomized crossover study with free-living subjects on self-selected diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who are representative of the U.S. population and at risk for cardiovascular disease (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).
The investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood pressure and LDL-cholesterol, and improve artery function (assessed by standard blood pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial stiffness) compared to the control group and baseline.
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
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index of 25-36 kg/m2
- •And, at least one of the following:
- •LDL-C above 116 mg/dL (3.0 mmol/L)
- •Systolic blood pressure 120-159 mmHg
- •Diastolic blood pressure 80-99 mmHg
- •Increased waist circumference: ≥94 cm for men and ≥80 cm for women
- •Elevated glucose (≥ 100 mg/dL and < 126 mg/dL)
- •Triglycerides: above 150 mg/dL (1.69 mmol/L) and below 350 mg/dL (3.95 mmol/L)
- •Low HDL-cholesterol: <40 mg/dL (< 1.03 mmol/L) for men and < 50 mg/dL (<1.29 mmol/L) for women)
排除标准
- •Allergies to the test foods
- •History of cardiovascular disease, stage II hypertension (BP 160/100 mmHg), kidney disease, diabetes or inflammatory diseases such as gastrointestinal disorders and rheumatoid arthritis
- •Use of medication/supplements for elevated lipids, blood pressure, or glucose
结局指标
主要结局
LDL Cholesterol
时间窗: 4 weeks
serum low-density cholesterol concentration
次要结局
- HDL-cholesterol, non-HDL cholesterol, triglycerides(4 weeks)
- Central blood pressure(4 weeks)
- Pulse wave velocity(4 weeks)
- Brachial blood pressure(4 weeks)
- Plasma glucose(4 weeks)
- High-sensitivity C-reactive protein(4 weeks)
- Serum insulin(4 weeks)