NCT00706888

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 30, 2008

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

First QC Date

June 26, 2008

Last Update Submit

July 3, 2009

Conditions

Cardiovascular Risk Factors

Keywords

Reduction of cardiovascular factor of risk

Study Arms (4)

1

ACTIVE COMPARATOR

Female with active product

Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols

2

ACTIVE COMPARATOR

Male with active product

Dietary Supplement: Vitamins B6, B9 and B12 and polyphenols

3

PLACEBO COMPARATOR

Female with placebo

Dietary Supplement: placebo

4

PLACEBO COMPARATOR

Male with placebo

Dietary Supplement: placebo

Interventions

Vitamins B6, B9 and B12 and polyphenolsDIETARY_SUPPLEMENT
12
placeboDIETARY_SUPPLEMENT
34

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Food allergy
  • Cardiovascular pathology
  • Medical treatment for cholesterol
  • Higher consumption for dairy product and red fruit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis

Nantes, France

Location

MeSH Terms

Interventions

Vitamin B 12Polyphenols

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 26, 2008

First Posted

June 30, 2008

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

FR(1)