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

Elvir SAS

Status: Completed

Conditions: Cardiovascular Risk Factors

Treatments: Dietary Supplement: placebo; Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00706888

Etude 9108

Details and patient eligibility

About

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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

64 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

Female with active product

Treatment:

Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols

2

Active Comparator group

Description:

Male with active product

Treatment:

Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols

3

Placebo Comparator group

Description:

Female with placebo

Treatment:

Dietary Supplement: placebo

4

Placebo Comparator group

Description:

Male with placebo

Treatment:

Dietary Supplement: placebo