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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
Sponsor:
Information provided by (Responsible Party):
Danone Research

Tracking Information
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)
Condition  ICMJE Mildly Hypercholesterolemic Subjects
Intervention  ICMJE
  • Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)
    1 = Intervention 1 (2 test products / day)
  • Other: 2-Low fat fermented dairy product (control)
    2 = Intervention 2 (2 control products/day)
Study Arms  ICMJE
  • Active Comparator: 1 = Tested product
    Intervention: Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)
  • Placebo Comparator: 2 = Control product
    Intervention: Other: 2-Low fat fermented dairy product (control)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2016)
194
Original Actual Enrollment  ICMJE
 (submitted: April 7, 2012)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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