Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)
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ClinicalTrials.gov Identifier: NCT01574469 |
Recruitment Status :
Completed
First Posted : April 10, 2012
Last Update Posted : December 7, 2016
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Sponsor:
Danone Research
Information provided by (Responsible Party):
Danone Research
Tracking Information | |||
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First Submitted Date ICMJE | April 7, 2012 | ||
First Posted Date ICMJE | April 10, 2012 | ||
Last Update Posted Date | December 7, 2016 | ||
Study Start Date ICMJE | September 2004 | ||
Actual Primary Completion Date | December 2004 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France) | ||
Official Title ICMJE | Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia | ||
Brief Summary | 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. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) |
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Condition ICMJE | Mildly Hypercholesterolemic Subjects | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
194 | ||
Original Actual Enrollment ICMJE |
242 | ||
Actual Study Completion Date ICMJE | August 2005 | ||
Actual Primary Completion Date | December 2004 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | France | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01574469 | ||
Other Study ID Numbers ICMJE | NU114 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Danone Research | ||
Study Sponsor ICMJE | Danone Research | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Danone Research | ||
Verification Date | December 2016 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |