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Effect of Water Intake on the DNA Adducts Formation

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ClinicalTrials.gov Identifier: NCT01583387
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Danone Research

Study Description
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Brief Summary:
The main purpose of the study is to assess the effect of water intake on the formation of 4-ABP DNA adducts.

Condition or disease Intervention/treatment Phase
Healthy Adults Other: 1-Increased water intake regimen Other: 2-Non-modified water intake regimen Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Proof of Concept of the Effect of Water Intake on the DNA Adducts Formation
Study Start Date : February 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
1= Intervention Other: 1-Increased water intake regimen
Arm 1-Intervention
2= Control Other: 2-Non-modified water intake regimen
Arm 2-Control


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583387


Locations
France
Centre CAP
Montpellier, France
Sponsors and Collaborators
Danone Research
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01583387     History of Changes
Other Study ID Numbers: NU340
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016

Keywords provided by Danone Research:
healthy adults
urinary adducts
water intake