- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01574469
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)
December 6, 2016 updated by: Danone Research
Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia
The purpose of this study is to investigate the effect on cholesterolemia profile of a low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
194
Phase
- Not Applicable
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
-
-
-
Paris, France, 75013
- Hôpital Pitié-Salpétrière
-
-
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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- male and female aged 18-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy and without any other hypocholesterolemic treatment, accepting to follow the AFSSAPS dietary recommendations for hypercholesterolemic patients, affiliated to a health coverage system, agreeing to a written informed consent
Exclusion Criteria:
- Subject with plasma triglycerides (TG) levels>250 mg/dL, with any cardiovascular event in the last 6 months, taking any hypocholesterolemic treatment) other than statin in monotherapy, Diabetic (type I and type II), receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with any acute or chronic disease which could impact on results of the study
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?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1 = Tested product
|
1 = Intervention 1 (2 test products / day)
|
Placebo Comparator: 2 = Control product
|
2 = Intervention 2 (2 control products/day)
|
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
September 1, 2004
Primary Completion (Actual)
December 1, 2004
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
April 7, 2012
First Submitted That Met QC Criteria
April 7, 2012
First Posted (Estimate)
April 10, 2012
Study Record Updates
Last Update Posted (Estimate)
December 7, 2016
Last Update Submitted That Met QC Criteria
December 6, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- NU114
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.
Clinical Trials on Mildly Hypercholesterolemic Subjects
-
Danone ResearchCompletedMildly Hypercholesterolemic SubjectsCanada
-
Danone ResearchCompletedMildly Hypercholesterolemic SubjectsUnited Kingdom
-
Danone ResearchCompletedMildly Hypercholesterolemic SubjectsItaly
-
Danone ResearchCompletedMild Hypercholesterolemic SubjectsGermany
-
Danone JapanCompletedNormal and Mild Hypercholesterolemic SubjectsJapan
-
Unilever R&DCompletedHealthy | Mildly Elevated Cholesterol LevelsSweden
-
BiogenCompletedHealthy Adult Subjects | Healthy Elderly SubjectsUnited States
-
Novartis PharmaceuticalsCompletedHeart Failure With Reduced Ejection Fraction (HFrEF) | or Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)Netherlands, United States
-
PfizerCompletedHealthy Adult Subjects and Healthy Elderly SubjectsBelgium
Clinical Trials on 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)
-
Danone ResearchCompletedMild Hypercholesterolemic SubjectsGermany
-
Danone JapanCompletedNormal and Mild Hypercholesterolemic SubjectsJapan
-
Danone ResearchCompletedHypercholesterolemiaUnited States
-
Danone SpainCompletedHypercholesterolemiaSpain
-
Danone ResearchCompletedMildly Hypercholesterolemic SubjectsItaly
-
Danone JapanCompletedHealthy | Mild HypercholesterolemiaJapan
-
Danone ResearchCompletedMildly Hypercholesterolemic SubjectsCanada
-
Danone ResearchCompletedMildly Hypercholesterolemic SubjectsUnited Kingdom