Effect of Water Intake on the DNA Adducts Formation

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

Study Description

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

• 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

Arms and Interventions

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

Eligibility Criteria

• 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

Locations

France

Centre CAP

Montpellier, France

Sponsors and Collaborators

Danone Research

More Information

• Responsible Party: Danone Research
• ClinicalTrials.gov Identifier: NCT01583387
• Other Study ID Numbers: NU340
• First Posted: April 24, 2012
• Last Update Posted: October 10, 2016
• Last Verified: October 2016

Keywords provided by Danone Research:

healthy adults; urinary adducts; water intake