NCT02628990已完成不适用
The Effect of Plant Stanol Ester Yoghurt Drinks With or Without Added Camelina Oil on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations
Raisio Group0 个研究点目标入组 155 人开始时间: 2005年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 主要终点
- Absolute change in serum LDL-cholesterol
研究概览
简要总结
The aim is to investigate the effects of yoghurt drinks containing two doses of plant stanol ester either with or without added camelina oil on the serum cholesterol levels in moderately 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI < 30 kg/m2
- •moderate hypercholesterolemia (fasting total cholesterol between 5-8 mmol/l)
- •serum triglycerides < 3 mmol/l.
- •normal liver, kidney and thyroid function
- •subjects must voluntarily sign the informed consent
排除标准
- •use of cholesterol lowering foods or dietary supplements within 21 days before the start of the intervention
- •lipid lowering medication
- •history of unstable coronary artery disease (myocardial infarction, coronary artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months, diabetes, hyperglycemia, temporal ischemic attack and malignant diseases
- •pregnancy or lactation
- •alcohol abuse
- •subjects with intolerance to any ingredient of the test products
结局指标
主要结局
Absolute change in serum LDL-cholesterol
时间窗: 4 weeks
Absolute change \[end of intervention - start of intervention\] in serum LDL-cholesterol between experimental and placebo groups, mmol/l
Percentual change in serum LDL-cholesterol
时间窗: 4 weeks
Percentual change \[end of intervention - start of intervention\] in serum LDL-cholesterol between experimental and placebo groups
次要结局
- Percentual change in serum total cholesterol(4 weeks)
- Absolute change in serum triglycerides(4 weeks)
- Absolute change in serum total cholesterol(4 weeks)
- Percentual change in serum non-HDL cholesterol(4 weeks)
- Percentual change in serum triglycerides(4 weeks)
- Absolute change in serum non-HDL cholesterol(4 weeks)
研究者
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