NCT02990260已完成不适用
Effect of Saccharomyces Cerevisiae in LDL Cholesterol
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Plasma LDL cholesterol
研究概览
简要总结
The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate hypercholesterolemia (LDL cholesterol between 1.3 and 1.9 g/L) with maximum 1 associated cardiovascular risk factor.
排除标准
- •Total cholesterol > 3.5 g/L (on an empty stomach)
- •Triglycerides > 3 g/L (on an empty stomach)
- •Familial hypercholesterolemia (IIa type)
- •Diabete mellitus treated or not
- •Subjects having consumed drugs known for their impact on lipid metabolism (statines, ezetimibes, colestyramin, fibrate...) in the month before beginning if the study and/or susceptible to consume such drugs during the study
- •Subjects having consumed food supplements or functional foods known for their impact on cholesterolemia (phytosterols, phytostanols, policosanols, beta-glucans...) in the month before the study and/or susceptible to consume such products during the study
- •Subjects having consumed probiotics food supplements in the month before the study and/or susceptible to consume such products during the study
- •Subjects following a low diet regimen (intakes < 1500 kcal/day) in the month before the study and/or susceptible to start such a regimen during the study
- •Food behaviour disorders diagnosed
- •Subjects with rare serious diseases (rare digestive diseases, renal failure, cardiovascular diseases, tumor...) or having endure a serious surgery
- •Subjects having endure bariatric surgery or having a gastric bypass in place
- •Pregnant or lactating women
- •Women willing a pregnancy Excessive alcohol consumption
- •Susceptible to modify their tobacco consumption before the end of the study
研究组 & 干预措施
Live Saccharomyces cerevisiae
Active Comparator
Live Saccharomyces cerevisiae. 2 capsules per day (1 g).
干预措施: Saccharomyces cerevisiae (Dietary Supplement)
Yeast cell wall
Active Comparator
Yeast cell wall. 2 capsules a day (700 mg).
干预措施: Lynside Wall Basic (Dietary Supplement)
Placebo
Placebo Comparator
Maize starch and magnesium stearate. 2 capsules a day.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Plasma LDL cholesterol
时间窗: 8 weeks
次要结局
- LDL cholesterol(4 weeks)
- Apo A1(4 weeks, 8 weeks)
- Total cholesterol(4 weeks, 8 weeks)
- HDL cholesterol(4 weeks, 8 weeks)
- Apo B(4 weeks, 8 weeks)
- Triglycerides(4 weeks, 8 weeks)
- ALAT(4 weeks, 8 weeks)
- gamma GT(4 weeks, 8 weeks)
- ASAT(4 weeks, 8 weeks)
研究者
研究点 (2)
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