NCT00860509已完成不适用
Phyteaux-II- Regulation of Cholesterol Absorption: Response of LDL to Low and Naturally High Phytosterol Diets
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fecal cholesterol excretion
研究概览
简要总结
The objective of this study is to compare cholesterol absorption and metabolism after feeding diets naturally low or high in phytosterols. All meals will be prepared in a metabolic kitchen and analyzed for phytosterols. In a randomized crossover design a group of up to 25 healthy subjects will consume diets containing either 100 mg/day or 600 mg/day phytosterols for 4 weeks. At the end of each dietary period percent cholesterol absorption, fecal cholesterol excretion and LDL cholesterol level will be measured. The hypothesis is that LDL cholesterol and cholesterol excretion will be improved on the high phytosterol diet even though macronutrient composition, mineral intake and fiber consumption are similar.
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
- •Male or female of any race or ethnicity between 18 to 80 years of age, inclusive;
- •Body mass index between 20-35 kg/m2;
- •LDL-cholesterol between 100-189 mg/dL based on the average of duplicate screening measures. If the two LDL-C levels differ by more than 30 mg/dL, a third test will be scheduled with all three results averaged;
- •Free of chronic disease;
- •Willing to eat only the foods that are provided by the Center during the diet periods;
- •Willing to consume no more than 1 alcoholic drink per day.
- •Willing to abstain from the consumption of alcohol for 48-hours prior to blood draw days;
- •Willing to drink no more than 5 cups of caffeine-containing beverages a day.
排除标准
- •Age < 18 or > 80 years;
- •Based on duplicate screening laboratory values: 1) LDL-C > or = 190 mg/dL; 2) TG > or = 250 mg/dL; 3) blood pressure > or = 160 mm Hg systolic or 95 mm Hg diastolic;
- •Documented presence of atherosclerotic disease;
- •Diabetes mellitus;
- •Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease;
- •Body mass index > 35;
- •For women, pregnancy, breast feeding or postpartum < 6 months;
- •For women, peri-menopausal;
- •History of drug or alcohol abuse;
- •History of depression or mental illness requiring treatment or medication within the last 6 months;
- •Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence;
- •Chronic use of over-the-counter medication which would interfere with study endpoints including laxatives and antacids;
- •Lifestyle or schedule incompatible with the study protocol;
- •Planned continued use of dietary supplements through the study trial;
- •Taking any lipid-lowering, or other medications known to affect blood cholesterol
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
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Intralumenal Effects on Cholesterol Absorption/SynthesisHealthyNCT00328211Children's Hospital Medical Center, Cincinnati35
已完成
1 期
Cholesterol Metabolism in Heterozygous PhytosterolemiaCardiovascular DiseaseNCT01102647University of Manitoba26
已完成
不适用
Cholesterol Absorption and Cholesterol synthesis in High-risk patiEnts (CACHE study)1. Cardiovascular disease (coronary arterial disease, cerebrovascular disease, peripheral arterial disease) 2. Conditions at high risk of cardiovascular disease (diabetes mellitus, chronic kidney disease including stage 5D) 3. Those who do not have the above diseasesJPRN-UMIN000030635Osaka City University3,000
已完成
不适用
Addition of Phytosterols to a Low Phytosterol DietHypercholesterolemiaCoronary Heart DiseaseNCT00860054Washington University School of Medicine18
已完成
4 期
Therapeutic effects of cholesterol absorption inhibitor on renal function in patients with chronic kidney diseaseChronic kidney disease HypercholesterolemiaJPRN-UMIN000002528Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine50