NCT03284918已完成不适用
Effect of a Cereal Based Snack Bar With Added Plant Stanol Ester on Serum Total and Lipoprotein Lipids
Raisio Group0 个研究点目标入组 71 人开始时间: 2016年1月1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
- 71
- 主要终点
- Percentage change in serum LDL cholesterol
研究概览
简要总结
The purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate hypercholesterolemia.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Serum total cholesterol 5.2-8.5 mmol/l
- •Serum triglycerides < 3 mmol/l
- •Signed written informed consent
排除标准
- •Abnormal liver, kidney and thyroid function
- •Use of lipid lowering medication
- •Consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2
- •History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months
- •Diagnosed type 1 or type 2 diabetes requiring medical treatment
- •History of recent temporal ischemic attack or malignant diseases (< 5 yrs)
- •Celiac disease, or allergy or intolerance to the ingredients of the test products
- •Medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet
- •Subjects with alcohol abuse (> 4 portion per day)
- •Pregnancy or planned pregnancy or lactating
研究组 & 干预措施
Plant stanol ester
Experimental
Cereal based snack bar with added plant stanol ester (0.8 g plant stanols/bar). Two bars consumed daily as a snack, between meals, for 4 weeks (1.6 g plant stanols/d).
干预措施: Plant stanol ester (Dietary Supplement)
Placebo
Placebo Comparator
Cereal based snack bar without plant stanol ester. Two bars consumed daily as a snack, between meals, for 4 weeks (0 g plant stanols/d).
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Percentage change in serum LDL cholesterol
时间窗: 4 weeks
次要结局
- Absolute change in serum LDL cholesterol (mmol/l)(4 weeks)
- Absolute and percentage change in serum total, HDL- and non-HDL cholesterol and serum total triglycerides(4 weeks)
研究者
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