Effect of Water Intake on the DNA Adducts Formation

NCT01583387 | Completed

• 1 other identifier: NU340
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adults

Keywords

healthy adults; urinary adducts; water intake

Study Arms (2)

1= Intervention

OTHER

Other: 1-Increased water intake regimen

2= Control

OTHER

Other: 2-Non-modified water intake regimen

Interventions

1-Increased water intake regimen OTHER

Arm 1-Intervention

1= Intervention

2-Non-modified water intake regimen OTHER

Arm 2-Control

2= Control

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 having received 4500 euros indemnities for participation in clinical trials in the 12 previous months (including participation in the present study)

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

Centre CAP

Montpellier, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 24, 2012
• Study Start: February 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

FR (1)