NCT01583387已完成不适用
Proof of Concept of the Effect of Water Intake on the DNA Adducts Formation
Danone Research1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2011年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
研究概览
简要总结
The main purpose of the study is to assess the effect of water intake on the formation of 4-ABP DNA adducts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects 20 to 45 years old (bound included)
- •Smoker with at least 15 cigarettes/day
- •Subjects with body mass index between 18 and 27kg/m2 (bound included)
- •Subjects with a 3-meal diet (breakfast, lunch, dinner)
- •Subjects who have an easy daily access to internet
- •Subjects able to communicate well with the investigator and willing to comply the requirement of the study
- •Subjects who have signed the form of informed consent and are registered to the French national welfare system
排除标准
- •Subjects presenting evidence or history of severe or acute disease which could affect the results of the study or the vital status
- •Subject practising physical activity in an intensive way according to the investigator judgment.
- •Subject with a history of metabolic disease or with acute or chronic gastrointestinal disease except appendicectomy
- •Subjects with diagnosed urinary tract disease
- •Subjects with diagnosed lung or respiratory disease
- •Subjects consuming regularly more than 3 units of alcohol per day
- •Subjects who take drugs or presenting drug addiction (cannabis, opioids, amphetamines.)
- •Subjects presenting a situation interfering with the outcomes of the study according to the investigator opinion
- •Subjects working with painting, dry cleaning, dyes, pesticides, aluminium or alphalt
- •Subjects who eat charcoaled food more than three meals/week
- •Subjects with a vegetarian diet
- •Subjects under local or general treatment which can modify measurements performed in the study, in particular the assessment of the hydration status (diuretic intake, or treatment interfering with metabolism and nutrition behaviour)
- •Subjects planning to stop or reducing smoking or change their cigarette brand within the next 3 months
- •Subjects in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject
- •Subjects currently in a exclusion period following participation in another clinical trial
- •Subjects having received 4500 euros indemnities for participation in clinical trials in the 12 previous months (including participation in the present study)
研究者
研究点 (1)
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