Study on Effects of a Dairy Product Based on Polyphenols and Enriched With Vitamins B6, B9 and B12 on Some Cardiovascular Factor of Risk

This study has been completed.

Sponsor:

Collaborator:

BioFortis

Information provided by:

Elvir SAS

ClinicalTrials.gov Identifier:

NCT00706888

First received: June 26, 2008

Last updated: July 3, 2009

Last verified: July 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	June 26, 2008
Last Updated Date	July 3, 2009
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00706888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study on Effects of a Dairy Product Based on Polyphenols and Enriched With Vitamins B6, B9 and B12 on Some Cardiovascular Factor of Risk
Official Title ^ICMJE	Not Provided
Brief Summary	We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Cardiovascular Risk Factors
Intervention ^ICMJE	Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols Dietary Supplement: placebo
Study Arm (s)	Active Comparator: 1 Female with active product Intervention: Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols Active Comparator: 2 Male with active product Intervention: Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols Placebo Comparator: 3 Female with placebo Intervention: Dietary Supplement: placebo Placebo Comparator: 4 Male with placebo Intervention: Dietary Supplement: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	64
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: BMI less than 33 kg/m² Waist measurement higher than 90 cm for woman and 100 cm for man Normal or controled blood pressure (less than 16/9) non-smoker Female with contraception Exclusion Criteria: Food allergy Cardiovascular pathology Medical treatment for cholesterol Higher consumption for dairy product and red fruit
Gender	Both
Ages	18 Years to 74 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT00706888
Other Study ID Numbers ^ICMJE	Etude 9108
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Elvir SAS
Collaborators ^ICMJE	BioFortis
Investigators ^ICMJE	Not Provided
Information Provided By	Elvir SAS
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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