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

Not Applicable

Completed

• Conditions: Mildly Hypercholesterolemic Subjects
• Interventions: Other: 2-Low fat fermented dairy product (control); Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)

• Registration Number: NCT01574469
• Lead Sponsor: Danone Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2004-12
• Study Completion: 2005-08
• Study First Submitted: 2012-04-07
• Study First Submitted QC: 2012-04-07
• Study First Posted: 2012-04-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 = Control product	2-Low fat fermented dairy product (control)	-
1 = Tested product	1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)	-

Trial Locations

Locations (1)

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France