Effect of Water Intake on the DNA Adducts Formation

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583387
• Other study ID #: NU340
• Status: Completed
• Phase: N/A
• First received: April 20, 2012
• Last updated: October 7, 2016
• Start date: February 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2016
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : AFSSAPS
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Other:
• 1-Increased water intake regimen
Arm 1-Intervention
• 2-Non-modified water intake regimen
Arm 2-Control

Locations

Country	Name	City	State
France	Centre CAP	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

France,