Effect of Water Intake on the DNA Adducts Formation

October 7, 2016 updated by: Danone Research

Proof of Concept of the Effect of Water Intake on the DNA Adducts Formation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France
        • Centre CAP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1= Intervention
Other: 1-Increased water intake regimen
Arm 1-Intervention
Other: 2= Control
Other: 2-Non-modified water intake regimen
Arm 2-Control

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 20, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NU340

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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