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Effect of Water Intake on the DNA Adducts Formation

This study has been completed.
Information provided by (Responsible Party):
Danone Research Identifier:
First received: April 20, 2012
Last updated: October 7, 2016
Last verified: October 2016
The main purpose of the study is to assess the effect of water intake on the formation of 4-ABP DNA adducts.

Condition Intervention
Healthy Adults
Other: 1-Increased water intake regimen
Other: 2-Non-modified water intake regimen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Proof of Concept of the Effect of Water Intake on the DNA Adducts Formation

Resource links provided by NLM:

Further study details as provided by Danone Research:

Enrollment: 65
Study Start Date: February 2011
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1= Intervention Other: 1-Increased water intake regimen
Arm 1-Intervention
2= Control Other: 2-Non-modified water intake regimen
Arm 2-Control


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01583387

Centre CAP
Montpellier, France
Sponsors and Collaborators
Danone Research
  More Information

Responsible Party: Danone Research Identifier: NCT01583387     History of Changes
Other Study ID Numbers: NU340 
Study First Received: April 20, 2012
Last Updated: October 7, 2016
Health Authority: France : AFSSAPS

Keywords provided by Danone Research:
healthy adults
urinary adducts
water intake processed this record on October 26, 2016