Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01583387
Previous Study | Return to List | Next Study

Effect of Water Intake on the DNA Adducts Formation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 20, 2012
First Posted Date  ICMJE April 24, 2012
Last Update Posted Date October 10, 2016
Study Start Date  ICMJE February 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Water Intake on the DNA Adducts Formation
Official Title  ICMJE Proof of Concept of the Effect of Water Intake on the DNA Adducts Formation
Brief Summary The main purpose of the study is to assess the effect of water intake on the formation of 4-ABP DNA adducts.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Adults
Intervention  ICMJE
  • Other: 1-Increased water intake regimen
    Arm 1-Intervention
  • Other: 2-Non-modified water intake regimen
    Arm 2-Control
Study Arms  ICMJE
  • 1= Intervention
    Intervention: Other: 1-Increased water intake regimen
  • 2= Control
    Intervention: Other: 2-Non-modified water intake regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October¬†7,¬†2016)
65
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01583387
Other Study ID Numbers  ICMJE NU340
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Danone Research
Study Sponsor  ICMJE Danone Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Danone Research
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP