Regulation of Cholesterol Absorption: LDL Cholesterol Response to a Combination of Phytosterols and Ezetimibe (Phyto-3)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Cholesterol Excretion
研究概览
简要总结
Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear to have different mechanisms of action. The investigators' hypothesis is that phytosterols and ezetimibe given together will block cholesterol absorption in an additive fashion. In a randomized, placebo-controlled crossover trial the effects of placebo, ezetimibe treatment and ezetimibe plus phytosterol treatment will be measured.
详细描述
The investigators will perform a randomized, placebo-controlled crossover feeding study in 25 subjects with greater than ideal levels of LDL cholesterol who do not require anti-cholesterol drug treatment. Subjects will consume a baseline diet provided by a feeding center that is deficient in phytosterols for three periods of 21 days separated by 7-day washout periods. Treatments will be given in random order During period B placebo phytosterols and placebo ezetimibe will be given; during period C placebo phytosterols and active ezetimibe will be given; during period A active phytosterols and active ezetimibe will be given. Study endpoints are fecal cholesterol excretion and percent cholesterol absorption determined by gas chromatography/mass spectrometry and circulating LDL cholesterol.
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)
盲法说明
Phytosterols solutions were provided as food oil only (placebo) or food oil containing 2000 mg/day phytosterols (Phytosterols). Active and placebo ezetimibe tablets were provided by Merck.
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;
- •Body mass index between 20 - 35 kg/m2;
- •LDL-cholesterol between 130 - 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 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 >=190 mg/dL; 2)TG >=250 mg/dL;3)blood pressure >= 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;
- •For women, sexually active but not practicing effective birth control methods;
- •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.
研究组 & 干预措施
Crossover order CAB
The order of treatments is C (active ezetimibe and placebo phytosterols), A (phytosterols + ezetimibe), and B (double placebo).
干预措施: Placebo (Other)
Crossover order BCA
The order of treatments is B (double placebo), C (active ezetimibe and phytosterol placebo), and A (phytosterols + ezetimibe).
干预措施: Ezetimibe (Drug)
Crossover order ABC
The order of treatments is A (phytosterols + ezetimibe), B (double placebo), and C (active ezetimibe and phytosterol placebo).
干预措施: Ezetimibe (Drug)
Crossover order ABC
The order of treatments is A (phytosterols + ezetimibe), B (double placebo), and C (active ezetimibe and phytosterol placebo).
干预措施: Phytosterols + ezetimibe (Other)
Crossover order ABC
The order of treatments is A (phytosterols + ezetimibe), B (double placebo), and C (active ezetimibe and phytosterol placebo).
干预措施: Placebo (Other)
Crossover order BCA
The order of treatments is B (double placebo), C (active ezetimibe and phytosterol placebo), and A (phytosterols + ezetimibe).
干预措施: Phytosterols + ezetimibe (Other)
Crossover order BCA
The order of treatments is B (double placebo), C (active ezetimibe and phytosterol placebo), and A (phytosterols + ezetimibe).
干预措施: Placebo (Other)
Crossover order BAC
The order of treatments is B (double placebo), A (phytosterols + ezetimibe), and C (active ezetimibe and phytosterol placebo)
干预措施: Ezetimibe (Drug)
Crossover order BAC
The order of treatments is B (double placebo), A (phytosterols + ezetimibe), and C (active ezetimibe and phytosterol placebo)
干预措施: Phytosterols + ezetimibe (Other)
Crossover order BAC
The order of treatments is B (double placebo), A (phytosterols + ezetimibe), and C (active ezetimibe and phytosterol placebo)
干预措施: Placebo (Other)
Crossover order ACB
The order of treatments is A (phytosterols + ezetimibe), C (active ezetimibe and placebo phytosterols, and B (double placebo).
干预措施: Ezetimibe (Drug)
Crossover order ACB
The order of treatments is A (phytosterols + ezetimibe), C (active ezetimibe and placebo phytosterols, and B (double placebo).
干预措施: Phytosterols + ezetimibe (Other)
Crossover order ACB
The order of treatments is A (phytosterols + ezetimibe), C (active ezetimibe and placebo phytosterols, and B (double placebo).
干预措施: Placebo (Other)
Crossover order CAB
The order of treatments is C (active ezetimibe and placebo phytosterols), A (phytosterols + ezetimibe), and B (double placebo).
干预措施: Ezetimibe (Drug)
Crossover order CAB
The order of treatments is C (active ezetimibe and placebo phytosterols), A (phytosterols + ezetimibe), and B (double placebo).
干预措施: Phytosterols + ezetimibe (Other)
Crossover order CBA
The order of treatments is C (active ezetimibe and placebo phytosterols), B (double placebo), and A (phytosterols and ezetimibe).
干预措施: Ezetimibe (Drug)
Crossover order CBA
The order of treatments is C (active ezetimibe and placebo phytosterols), B (double placebo), and A (phytosterols and ezetimibe).
干预措施: Phytosterols + ezetimibe (Other)
Crossover order CBA
The order of treatments is C (active ezetimibe and placebo phytosterols), B (double placebo), and A (phytosterols and ezetimibe).
干预措施: Placebo (Other)
结局指标
主要结局
Cholesterol Excretion
时间窗: At the end of week 3 on each diet
Milligrams of fecal cholesterol and cholesterol metabolites excreted per day
Percent Cholesterol Absorption
时间窗: Determined on the final 5 days of each dietary period
Percent of intestinal cholesterol absorbed. Intestinal cholesterol is comprised of dietary cholesterol intake and endogenous cholesterol secreted into the intestinal lumen. Cholesterol absorption is the percent of intestinal cholesterol that is taken back up into the body and excluded from fecal excretion. It is also referred to as the efficiency of intestinal cholesterol absorption.
LDL Cholesterol
时间窗: At the end of week 3 on each diet
次要结局
未报告次要终点