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

Danone

Status: Completed

Conditions: Mildly Hypercholesterolemic Subjects

Treatments: 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)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01574469

NU114

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

194 participants in 2 patient groups, including a placebo group

1 = Tested product

Active Comparator group

Treatment:

Other: 1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)

2 = Control product

Placebo Comparator group

Treatment:

Other: 2-Low fat fermented dairy product (control)