NCT01544829已完成不适用
The Acute Effect of 2 Different Serving Regimens of Theobromine on Theobromine Concentration in the Blood & Physiological Effects
Unilever R&D1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年2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
- 12
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
The main aim of this study is to determine whether there is a difference in the physiological effects of theobromine when provided via a single serving compared to multiple servings adding up to the same amount of theobromine provided on a day.
This study also aims to study the pharmacokinetics of theobromine after administration once per day versus administration 4 times per day.
Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is given in 4 smaller doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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)
- •Age 40-70 years
- •BMI ≥ 18 and ≤ 30 kg/m2
- •Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged non clinically significant by research physician
- •Written informed consent
排除标准
- •Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
- •Diabetes mellitus
- •Reported weight loss or gain of 10% body weight or more during a period of 6 months prior to screening
- •Reported intense sporting activities > 10 h/week
- •Use of over-the -counter 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 run-in period.
- •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
- •High caffeine consumption: reported consumption of more than 8 cups/cans of caffeine-containing drinks per day, i.e. coffee, black or green tea and cola (also cola light, diet & zero) OR consumption of more than 1 energy drink per day
结局指标
主要结局
Heart rate
时间窗: 3 days
Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods
次要结局
- Blood pressure(Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods)
- Hematocrit(Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods)
- Serum blood lipids(Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods)
- Serum glucose and insulin concentrations(Measured on day 1 and 2 (at time points -5min, 3h, 5h, 10h and 24h) for 3 periods)
研究者
研究点 (1)
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