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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01574469
First received: April 7, 2012
Last updated: December 6, 2016
Last verified: December 2016
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
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: 194
Study Start Date: September 2004
Study Completion Date: August 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574469

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

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01574469     History of Changes
Other Study ID Numbers: NU114
Study First Received: April 7, 2012
Last Updated: December 6, 2016

Keywords provided by Danone Research:
Plant sterol - Cholesterol absorption - diet - dairy - LDL

ClinicalTrials.gov processed this record on June 23, 2017