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NCT00706888 Clinical Trial

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

Cardiovascular Risk Factors Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00706888
Other study ID # Etude 9108
Secondary ID
Status Completed
Phase N/A
First received June 26, 2008
Last updated July 3, 2009

Study information
Verified date July 2009
Source Elvir SAS
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 74 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

• placebo

Locations
Country Name City State
France Biofortis Nantes

Sponsors (2)
Lead Sponsor Collaborator
Elvir SAS BioFortis

Country where clinical trial is conducted

France, 

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