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Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (France)

This study has been completed.
Groupe Hospitalier Pitie-Salpetriere
Information provided by (Responsible Party):
Danone Research Identifier:
First received: April 7, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Official Title: Effect of Low-fat, Fermented Milk Enriched With Plant Sterols on Serum Lipid Profile in Moderate Hypercholesterolemia

Resource links provided by NLM:

Further study details as provided by Danone Research:

Enrollment: 242
Study Start Date: September 2004
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT01574469

Hôpital Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Danone Research
Groupe Hospitalier Pitie-Salpetriere
  More Information

Responsible Party: Danone Research Identifier: NCT01574469     History of Changes
Other Study ID Numbers: NU114 
Study First Received: April 7, 2012
Last Updated: April 7, 2012
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Danone Research:
Plant sterol - Cholesterol absorption - diet - dairy - LDL processed this record on October 27, 2016