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

NCT ID: NCT00706888

Last Updated: 2009-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Cardiovascular Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Female with active product

Group Type ACTIVE_COMPARATOR

Vitamins B6, B9 and B12 and polyphenols

Intervention Type DIETARY_SUPPLEMENT

2

Male with active product

Group Type ACTIVE_COMPARATOR

Vitamins B6, B9 and B12 and polyphenols

Intervention Type DIETARY_SUPPLEMENT

3

Female with placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

4

Male with placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vitamins B6, B9 and B12 and polyphenols

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioFortis

OTHER

Sponsor Role collaborator

Elvir SAS

INDUSTRY

Sponsor Role lead

Locations

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Biofortis

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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Etude 9108

Identifier Type: -

Identifier Source: org_study_id

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