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

This study has been completed.
Sponsor:
Collaborator:
HOPITAL PITIE-SALPETRIERE
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01574469
First received: April 7, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574469

Locations
France
Hôpital Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Danone Research
HOPITAL PITIE-SALPETRIERE
  More Information

No publications provided

Responsible Party: Danone Research
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013