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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:
ClinicalTrials.gov Identifier:
NCT00706888
First Posted: June 30, 2008
Last Update Posted: July 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
BioFortis
Information provided by:
Elvir SAS
June 26, 2008
June 30, 2008
July 7, 2009
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Complete list of historical versions of study NCT00706888 on ClinicalTrials.gov Archive Site
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Study on Effects of a Dairy Product Based on Polyphenols and Enriched With Vitamins B6, B9 and B12 on Some Cardiovascular Factor of Risk
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We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Cardiovascular Risk Factors
  • Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols
  • Dietary Supplement: placebo
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
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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
Sexes Eligible for Study: All
18 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00706888
Etude 9108
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Elvir SAS
BioFortis
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Elvir SAS
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP