NCT01629238

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
780

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

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

Study Start

First participant enrolled

October 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

June 25, 2012

Last Update Submit

October 7, 2016

Conditions

Cardiovascular Disease

Keywords

cardiovascular riskdairy enriched product with plant sterolsgeneral practitionersadults followed by general practitioners

Study Arms (2)

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 Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults followed by general practitionners

You may qualify if:

  • 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

You may not qualify if:

  • any clinical, psychological or language problem that would prevent from completing the questionaires or communicating with GP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BKL Consultant

Boulogne-Billancourt, 92100, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 27, 2012

Study Start

October 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 10, 2016

Record last verified: 2016-10

Locations

FR(1)