NCT03312816已完成不适用
The Effect of Oxidized Plant Sterol Intake on Serum Concentrations of Plant Sterol Oxidation Products (POP)
Unilever R&D2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年10月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- POP (plant sterol oxidation products) value
研究概览
简要总结
The study is a randomised, double-blind, placebocontrolled, parallel dose-response study with four study arms. Sixty subjects will be randomly allocated to consume study products containing varying amounts of plant sterol (PS) oxidation products (POP) or placebo for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy men and women as judged by study physician.
- •BMI > 18 and < 35 kg/m
- •Total cholesterol levels at screening ≥5.0 and ≤8.0 mmol/L
- •Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by the study physician.
排除标准
- •Recently (<6 months) diagnosed with cardiovascular event(s) (stroke, TIA (Transient ischemic attack), angina, myocardial infarction, heart failure), revascularization or systemic inflammatory conditions.
- •Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study.
- •Use of over-the-counter and prescribed medication which may interfere with study measurements (i.e. statins, ezetimibe, fibrates, diabetic drugs, angiotensin receptor blockers (ARB) and ACE (Angiotensin-converting enzyme) inhibitors)), to be judged by the principal investigator.
- •Use of oral antibiotics (with the exception of topical antibiotics) in 40 days or less prior to Day -
- •Pregnant or lactating women.
- •Reported alcohol consumption > 14 units/week (female) or > 21 units/week (male).
- •Reported intense sporting activities > 10 hours/week.
- •Reported weight loss or gain of 3 kg or more during a period of 6 months prior to screening.
- •Currently on a medically- or self-prescribed diet, or slimming diet, or the intention to use any kind of diet during the study.
- •Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.
研究组 & 干预措施
Hige dose
Active Comparator
high added POP
干预措施: cookies enriched with POP (Other)
Placebo
Placebo Comparator
0 mg/d added POP
干预措施: cookies enriched with POP (Other)
low dosage
Active Comparator
low added POP
干预措施: cookies enriched with POP (Other)
Medium dose
Active Comparator
medium added POP
干预措施: cookies enriched with POP (Other)
结局指标
主要结局
POP (plant sterol oxidation products) value
时间窗: 0 to 42 days
To estimate the change from baseline in serum POP concentration after intake of various POP doses.
次要结局
- Ratio of serum POP concentration(0 to 42 days)
- COP (cholesterol oxidation products) value(0 to 42 days)
研究者
研究点 (2)
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