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

Danone

Status

Completed

Conditions

Hypercholesterolemia

Treatments

Other: 3- Low fat drinkable fermented dairy product without plant sterols(control)

Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit

Other: 2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit

Study type

Interventional

Funder types

Industry

Identifiers

NCT01600820

NU146

Details and patient eligibility

About

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.

Enrollment

126 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 higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
higher than 100 mg/dl in individuals with a 10-year risk > 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
with or without statin monotherapy,
willing to respect the dietary advising delivered at the screening visit,
agreeing to a written informed consent

Exclusion criteria

subject with plasma triglycerides (TG) levels > 400 mg/dL,
with any cardiovascular event in the last 6 months,
subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,
diabetic (type I and type II),
presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,
pregnant or breast feeding women