Effect of Water Intake on the DNA Adducts Formation

This study has been completed.
Sponsor:
Collaborator:
Centre CAP
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01583387
First received: April 20, 2012
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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: 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:

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583387

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

No publications provided

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01583387     History of Changes
Other Study ID Numbers: NU340
Study First Received: April 20, 2012
Last Updated: April 23, 2012
Health Authority: France : AFSSAPS

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

ClinicalTrials.gov processed this record on September 15, 2014