Healthy AdultsNCT01583387
Effect of Water Intake on the DNA Adducts Formation
A study testing 1-Increased water intake regimen and 2-Non-modified water intake regimen in people with Healthy Adults, run by Danone Global Research & Innovation Center at 1 site in France.
Trial summary
The main purpose of the study is to assess the effect of water intake on the formation of 4-ABP DNA adducts. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- 1-Increased water intake regimen and 2-Non-modified water intake regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of Concept of the Effect of Water Intake on the DNA Adducts Formation
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
- Being tested
- 1-Increased water intake regimen, 2-Non-modified water intake regimen
- Keywords
- healthy adults, urinary adducts, water intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-Increased water intake regimenOther
Arm 1-Intervention
2-Non-modified water intake regimenOther
Arm 2-Control
| Study group | Role | What they receive |
|---|---|---|
| 1= Intervention | Other | Not described Receives: Other: 1-Increased water intake regimen |
| 2= Control | Other | Not described Receives: Other: 2-Non-modified water intake regimen |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583387
- Sponsor's protocol ID
- NU340
- Status last verified
- Oct 2016
- First submitted
- 20 Apr 2012
- Last updated
- 10 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept of the Effect of Water Intake on the DNA Adducts Formation
- ClinicalTrials.gov ID
- NCT01583387
- Acronym / sponsor ID
- NU340
- Conditions
- Healthy Adults
- Keywords
- healthy adults, urinary adducts, water intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to assess the effect of water intake on the formation of 4-ABP DNA adducts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1= Intervention | Other | Other: 1-Increased water intake regimen |
| 2= Control | Other | Other: 2-Non-modified water intake regimen |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-Increased water intake regimenArm 1-Intervention | Other | 1= Intervention |
| 2-Non-modified water intake regimenArm 2-Control | Other | 2= Control |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-Increased water intake regimen and 2-Non-modified water intake regimen in people with Healthy Adults, run by Danone Global Research & Innovation Center at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2016.