- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01629238
Characteristics of Plant Sterols Consumers in France
October 7, 2016 updated by: Danone Research
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 practitioners' database.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
780
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
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Boulogne-Billancourt, France, 92100
- BKL Consultant
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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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adults followed by general practitionners
Description
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
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?
Cohorts and Interventions
Group / Cohort |
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
June 25, 2012
First Submitted That Met QC Criteria
June 26, 2012
First Posted (Estimate)
June 27, 2012
Study Record Updates
Last Update Posted (Estimate)
October 10, 2016
Last Update Submitted That Met QC Criteria
October 7, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NU333
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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