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

July 3, 2009 updated by: Elvir SAS
We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Biofortis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Female with active product
Dietary supplement: Vitamins B6, B9 and B12 and polyphenols
Active Comparator: 2
Male with active product
Dietary supplement: Vitamins B6, B9 and B12 and polyphenols
Placebo Comparator: 3
Female with placebo
Dietary supplement: placebo
Placebo Comparator: 4
Male with placebo
Dietary supplement: placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elvir SAS

Collaborators

BioFortis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 26, 2008

First Submitted That Met QC Criteria

June 27, 2008

First Posted (Estimate)

June 30, 2008

Study Record Updates

Last Update Posted (Estimate)

July 7, 2009

Last Update Submitted That Met QC Criteria

July 3, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Etude 9108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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