Characteristics of Plant Sterols Consumers in France

This study has been completed.
Sponsor:
Collaborator:
Dr Pierre Bruneau - BKL consultant
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01629238
First received: June 25, 2012
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to describe the cardiovascular risk profile in subjects who consume a marketed drinkable low fat fermented milk enriched with plant sterol. Investigations are lead prospectively and retrospectively among adults enrolled from general practitionners' database.


Condition
Cardiovascular Disease

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by Danone Research:

Enrollment: 780
Study Start Date: October 2010
Groups/Cohorts
group 1
group 1 = consumers of marketed drinkable low fat fermented milk enriched with plant sterol
group 2
group 2 = non-consumers of marketed drinkable low fat fermented milk enriched with plant sterol

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

adults followed by general practitionners

Criteria

Inclusion Criteria:

  • male and female aged 18-70 years, regular visits to GP (at least once every six months within the past 2 years), agreeing to a written informed consent

Exclusion Criteria:

  • any clinical, psychological or language problem that would prevent from completing the questionaires or communicating with GP
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629238

Locations
France
BKL Consultant
Boulogne-Billancourt, France, 92100
Sponsors and Collaborators
Danone Research
Dr Pierre Bruneau - BKL consultant
  More Information

No publications provided

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01629238     History of Changes
Other Study ID Numbers: NU333
Study First Received: June 25, 2012
Last Updated: June 26, 2012
Health Authority: France : The Commission nationale de l'informatique et des libertés (CNIL)
France : Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé (CCTIRS)
France: Ministère de l'Enseignement supérieur et de la Recherche
France: Conseil National de l'Ordre des Médecins

Keywords provided by Danone Research:
cardiovascular risk
dairy enriched product with plant sterols
general practitioners
adults followed by general practitionners

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014