NCT00937898已完成不适用
BOLD (Beef in an Optimal Lean Diet) Effects on Established and Emerging Cardiovascular Disease (CVD) Risk Factors
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Lipids (Total cholesterol, LDL-C, HDL-C, TG)
研究概览
简要总结
The study is designed to assess the effects of a heart-healthy diet that includes lean beef as the primary source of high quality protein on risk factors for cardiovascular disease.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI > 20 and < 37
- •LDL-C level between the 50th and 90th percentile (±5% for assay variation) according to NHANES data for sex and age (ex. for men: 128-177 mg/dL and for women: 121-172 mg/dL)
- •TG level < 150 mg/dL
排除标准
- •self-reported history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease, and thyroid disease (unless controlled on medication)
- •high alcohol consumption (≥ 14 drinks/week)
- •intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens, stanol/sterol supplemented foods)
- •treatment with lipid-lowering agents (statins and fibrates) or blood pressure control medications
- •vegetarian diet
- •weight loss or gain ≥ 10% body weight in the previous 6 months,
- •lactation, pregnancy, or desire to become pregnant during the study
研究组 & 干预措施
DASH Diet
Experimental
High fruit and vegetable, low sodium diet
干预措施: BOLD+ Diet (Dietary Supplement)
DASH Diet
Experimental
High fruit and vegetable, low sodium diet
干预措施: BOLD diet (Dietary Supplement)
Average American Diet
Active Comparator
Typical American diet (16% protein, ~50% carbohydrate, 33% fat)
干预措施: BOLD+ Diet (Dietary Supplement)
Average American Diet
Active Comparator
Typical American diet (16% protein, ~50% carbohydrate, 33% fat)
干预措施: BOLD diet (Dietary Supplement)
结局指标
主要结局
Lipids (Total cholesterol, LDL-C, HDL-C, TG)
时间窗: End of each 5 week diet period (weeks 5, 11, 17, 23)
次要结局
- Apolipoprotein levels(End of each 5 week diet period (weeks 5, 11, 17, 23))
- Vascular function(End of each 5 week diet period (weeks 5, 11, 17, 23))
- Oxidative Stress(End of each 5 week diet period (weeks 5, 11, 17, 23))
研究者
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