The main purpose of the study is to assess the effect of water intake on the formation of
4-ABP DNA adducts.
Other: 1-Increased water intake regimen
Other: 2-Non-modified water intake regimen
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Locations near you
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Full eligibility criteria for NCT01583387
Ages eligible for Study
20 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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)
All locations for NCT01583387
View full eligibility
Tris trial is registered with FDA with number: NCT01583387. The sponsor of the trial is Danone Research and it is looking for 65 volunteers for the current phase.
Official trial title: Proof of Concept of the Effect of Water Intake on the DNA Adducts Formation
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