Effect of Water Intake on the DNA Adducts Formation

NCT ID: NCT01583387

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1= Intervention

Group Type: OTHER

1-Increased water intake regimen

Intervention Type: OTHER

Arm 1-Intervention

2= Control

Group Type: OTHER

2-Non-modified water intake regimen

Intervention Type: OTHER

Arm 2-Control

Interventions

1-Increased water intake regimen

Arm 1-Intervention

Intervention Type: OTHER

2-Non-modified water intake regimen

Arm 2-Control

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre CAP

Montpellier, , France

Countries

France

Other Identifiers

NU340

Identifier Type: -

Identifier Source: org_study_id