Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols

Danone

Status

Completed

Conditions

Hypercholesterolemia

Treatments

Dietary Supplement: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters

Dietary Supplement: 1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).

Study type

Interventional

Funder types

Industry

Identifiers

NCT01340287

NU281

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 of daily consumption in midly hypercholesterolemic people not treated by statins.

Enrollment

168 patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

male/female subject,
aged from 21 to 75 years,
BMI between 19 and 30 kg/m2,
LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy,
stabilized hypercholesterolemia,
accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
used to consume dairy products,
effective contraceptive methods used for female subjects,
having given written consent to take part in the study

Exclusion criteria

subject with plasma triglycerides (TG) levels ≥ 350 mg/dL,
having experienced any cardiovascular event in the last 6 months,
taking any hypocholesterolemic treatment,
diabetic subject (type I and type II),
smoking strictly more than 10 cigarettes / day,
heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women),
presenting known allergy or hypersensitivity to milk proteins,
known soy allergy,
refusing to stop the consumption of plant sterols-enriched products (other than the studied product),
receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
receiving a transplant and under immunosuppressor treatment,
currently involved in a clinical trial or in an exclusion period following participation in another clinical trial,
in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,
for female subject: pregnancy, breast feeding or intention to be pregnant during the study or subject likely to change her contraceptive method during the study