NCT01481389已完成不适用
The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
Unilever R&D2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2010年12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
- 152
- 试验地点
- 2
- 主要终点
- Blood lipids
研究概览
简要总结
The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters.
Hypothesis: theobromine has a positive effect on blood lipid parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
- •Willing and able to participate in the study protocol
- •Written informed consent
- •Age 40-70 years
- •10-year risk of developing CHD <10%, based on data from the Framingham Heart Study
- •BMI > 18 and < 30 kg/m2
- •Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by research physician
- •Willing to comply with the dietary restrictions of the study.
- •Accessible veins on arm(s) as determined by examination at screening
排除标准
- •Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
- •Diabetes mellitus
- •Reported alcohol consumption > 14 units/week (female) or > 21 units/week (male)
- •Currently on a medically prescribed diet, or slimming diet
- •Reported weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination
- •Reported intense sporting activities > 10 h/w
- •Use of prescribed medication which may interfere with study measurements, as judged by the physician
- •Use of antibiotics in the three months before screening or during the study.
- •Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself
- •Reported intolerance to test products or other food products provided during the study
- •Blood donation 1 month (males) or 2 months (females) prior to screening and during the study
- •Reported participation in another nutritional or biomedical trial 3 months before screening or during the study.
- •Extreme coffee consumption
结局指标
主要结局
Blood lipids
时间窗: after 4 weeks intervention
次要结局
- Blood pressure(After 4 weeks intervention)
- Heart rate(After 4 weeks intervention)
研究者
研究点 (2)
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