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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mildly Hypercholesterolemic Subjects Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test) Other: 2-Low fat fermented dairy product (control) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia
Study Start Date : September 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : August 2005

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 = Tested product 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)
Placebo Comparator: 2 = Control product Other: 2-Low fat fermented dairy product (control)
2 = Intervention 2 (2 control products/day)


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574469


Locations
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France
Hôpital Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Danone Research
More Information
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Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01574469    
Other Study ID Numbers: NU114
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Keywords provided by Danone Research:
Plant sterol - Cholesterol absorption - diet - dairy - LDL