Effect of the Consumption of a Fermented Dairy Product Enriched With Plant Sterols

Danone

Status

Completed

Conditions

Mild Hypercholesterolemic Subjects

Treatments

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

Other: 2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).

Study type

Interventional

Funder types

Industry

Identifiers

NCT01521156

NU312

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 sterols after 3 weeks of daily consumption in midly hypercholesterolemic people.

Enrollment

128 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male/female subject, aged from 18 to 75,with BMI between 18,5 and 30 kg/m², with LDL-cholesterol blood level between 130 mg/dL to 190 mg/dL without statin therapy.
Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subject.
Subject used to consume dairy products.
For female subjects: effective contraceptive methods used.
Subject having given written consent to take part in the study.

Exclusion criteria

Subject with blood triglycerides levels above 350 mg/dL.
Subject having experienced any cardiovascular event in the last 6 months.
Subject having sitosterolemia.
Subject taking any hypocholesterolemic treatment drugs.
Intake of blood lipid-regulating supplementation of blood lipid-regulating dietary supplements or functional food during the last 2 weeks before study start.
Diabetic subject (type I and type II).
Subject smoking strictly more than 10 cigarettes / day.
Subject with heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women).
Subject presenting known allergy or hypersensitivity to milk proteins.Subject with known soy allergy.
Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product).
Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
Subject receiving a transplant and under immunosuppressor treatment.
Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.
Subject 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.
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.
For female subject: subject likely to change her contraceptive method during the study.