NCT03380611已完成不适用
Effects of Wakame and Spirulina Consumption on Intestinal Cholesterol Absorption in Non- Hypercholesterolemic Men and Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Markers for intestinal cholesterol absorption
研究概览
简要总结
The primary objective of this study is to investigate the effects of wakame and spirulina consumption on intestinal cholesterol absorption.
详细描述
Objectives:
Secondary objectives are to investigate the effects of wakame and spirulina consumption on fasting markers for lipid metabolism, glucose metabolism and blood pressure.
Study design:
This study is a double-blinded, randomized, placebo-controlled, crossover intervention trial consisting of three intervention periods of 17 days each, separated by a minimum washout period of 14 days.
Study population:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 70 years;
- •BMI between 18 and 30 kg/m2;
- •Non-smoking;
- •No elevated serum triacylglycerol concentrations (< 4.5 mmol/L);
- •Willing to comply to the study protocol during the study;
- •Agreeing to be informed about medically relevant personal test-results.
排除标准
- •Not willing to abstain from any algae and/or seaweed consumption or algae/seaweed containing products two weeks before the start and during the trial;
- •Use of plant-sterol/stanol-enriched foods (e.g. Becel Proactive) or supplements in the four weeks prior to the screening and/or during the study;
- •Use of cholesterol or lipid-lowering medications (e.g. statins, bile-acid sequestrates, cholesterol absorption inhibitors);
- •Use of any kind of medication or a medically prescribed diet, which can interfere with the study;
- •Use of oral antibiotics in 40 days or less prior to the start of the study;
- •Use of food supplements that might interfere with study measurements (judged by the principal investigator) in four weeks or less prior to the start of the study;
- •Indications of treatment according to the Standard for Cardiovascular Risk Management from the Dutch General Practitioners community;
- •Any medical condition that might interfere with study (measurements), judged by the principal investigator, including cardiovascular diseases or events (e.g. acute myocardial infarction or cerebro-vascular accident), diabetes, asthma, COPD, rheumatoid arthritis, and gastro-intestinal diseases (e.g. inflammatory bowel disease);
- •Unstable body weight (weight gain or loss > 3 kg in the past 3 months);
- •Females who are pregnant, breast feeding or who may wish to become pregnant during the study;
- •Consumption of > 14 (males) or > 10 (females) alcoholic consumptions a week;
- •Reported intense sporting activities > 10 hours a week;
- •• Abuse of drugs;
- •Participation in any other biomedical trial four weeks prior to the screening visit;
- •Having donated >150 ml blood within 1 month prior to the screening visit, planning to donate blood during the study or within one month after finishing the study;
- •Impossible or difficult to puncture as evidenced during the screening visit.
结局指标
主要结局
Markers for intestinal cholesterol absorption
时间窗: Difference in outcomes between interventions and control at 17 days
Serum cholesterol-standardized campesterol concentrations will be measured as a marker for intestinal cholesterol absorption
次要结局
- Markers for cholesterol synthesis(Difference in outcomes between interventions and control at 17 days)
- Blood pressure(Difference in outcomes between interventions and control at 17 days)
- Lipids(Difference in outcomes between interventions and control at 17 days)
- Glucose concentrations(Difference in outcomes between interventions and control at 17 days)
研究者
研究点 (2)
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