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

Verified by: Elvir SAS, July 2009
First Received: June 26, 2008 | Last Updated: July 3, 2009 | Phase: N/A | Start Date: 
Overall Status: Completed | Estimated Enrollment: 64
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We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk...

Brief Summary

We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Intervention(s) in this Clinical Trial

  • Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols
  • Dietary Supplement: placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Female with active product
  • Active Comparator: 2
    • Male with active product
  • Placebo Comparator: 3
    • Female with placebo
  • Placebo Comparator: 4
    • Male with placebo

Criteria for Participation in this Clinical Trial

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 74 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Elvir SAS Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00706888

Study ID Number: Etude 9108

ClinicalTrials.gov Identifier: NCT00706888

Health Authority: France: Afssaps - French Health Products Safety Agency

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00706888