Regulation of Cholesterol Absorption: Dose Response of LDL to Phytosterols Added to a Phytosterol-Poor Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Fecal cholesterol excretion
研究概览
简要总结
Studies have shown that phytosterols will lower LDL cholesterol. Typical diets can contain between 250 to 500 mg of naturally-occurring phytosterols. Long-term studies with phytosterol-containing products(such as margarines) have not taken into account the amounts of naturally occurring phytosterols in the diet. This means that the effects of small amounts of natural dietary phytosterols on LDL cholesterol are not known. In this study, we will examine the effects of phytosterols across a range of levels. The information will likely be used to further support and possibly extend the current dietary recommendations for phytosterol use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women are eligible who:
- •are of any race or ethnicity between 18 to 80 years of age;
- •are in generally good health;
- •have moderately elevated blood cholesterol(LDL cholesterol between 100 and 189 mg/dl)
- •will eat only the foods that are provided by the center during the diet periods;
- •will drink no more than 5 cups of caffeine-containing beverages a day;
- •will consume no more than 1 alcoholic drink a day;
- •will abstain from the consumption of alcohol for 48-hours prior to blood draw days
排除标准
- •are younger than 18 or older than 80 years;
- •have very high cholesterol(LDL cholesterol equal to or above 190 mg/dl or triglycerides equal to or above 250 mg/dl);
- •have very high blood pressure(equal to or above 160 mm Hg systolic or 95 mm Hg diastolic);
- •are overweight( BMI greater than 35 kg/m2)
- •are taking lipid-lowering, or any other medication known to affect blood cholesterol;
- •have diabetes mellitus, cancer, heart, liver and/or kidney disease, or chronic disease that might interfere with participation;
结局指标
主要结局
Fecal cholesterol excretion
时间窗: At the end of week 4 on each diet
次要结局
- intestinal cholesterol absorption(At the end of week 4 on each diet)
研究者
Richard E. Ostlund Jr., MD
Professor of Medicine
Washington University School of Medicine