NCT01629888已完成不适用
A Clinical Study for Evaluating the Safety of Excessive Consumption of a Plant Sterol-enriched Yoghurt Drink
Danone Japan1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年2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
- 48
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to investigate the safety of consumption of three times the standard dose of a yoghurt drink enriched with 1600 mg of plant sterols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male/female subjects,
- •aged 20-65 years old,
- •triglycerides (TG) levels under 400 mg/dL,
- •total cholesterol plasma level under 240 mg/dL (with half the subjects at entry under 200 mg/dL),
- •LDL-cholesterol plasma level under 160 mg/dL (with half the subjects at entry under 120 mg/dL),
- •non diabetic and non hypertensive,
- •accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (Japan Atherosclerosis Society guidelines),
- •effective contraceptive methods used for female subjects,
- •having given written consent to take part in the study
排除标准
- •subjects with sitosterolemia,
- •subjects with 200 ml of blood taken within the past month or 400 ml or more within the past 3 months,
- •taking any hypocholesterolemic treatment,
- •presenting known allergy or hypersensitivity to plant sterols,
- •dairy products and lactose, subject with heavy alcohol intake (> 60g/day),
- •receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
- •subjects receiving a transplant or under immunosuppressor treatment,
- •receiving treatment for any serious pathology.
- •for female subject:
- •pregnancy,
- •breast feeding or
- •intention to be pregnant during the study
研究组 & 干预措施
1 = Tested product
Experimental
干预措施: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols). (Other)
2 = Control product
Placebo Comparator
干预措施: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters (Other)
研究者
研究点 (1)
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