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

This study has been completed.

Sponsor:

Collaborator:

Groupe Hospitalier 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

Drug Information available for: Campesterol

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 (Adult, Senior)
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

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

Groupe Hospitalier Pitie-Salpetriere

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:	April 7, 2012
Health Authority:	France: Committee for the Protection of Personnes

Keywords provided by Danone Research:


Plant sterol - Cholesterol absorption - diet - dairy - LDL

ClinicalTrials.gov processed this record on September 23, 2016

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