We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk...
Date First Received: June 26, 2008
Last Updated: June 27, 2008
Verified by: Elvir SAS, June 2008
Clinical Trial Phase: N/A | Start Date:
Overall Status: Recruiting
Estimated Enrollment: 64
Brief Summary
Condition Keyword(s):
We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk.
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
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 Sponsor Information
Lead Sponsor: Elvir SAS
Overall Clinical Trial Officials and Contacts
Overall Contact: Biofortis
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
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
Clinical Trials Authorship and Review
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