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

Danone

Status: Completed

Conditions: Mildly Hypercholesterolemic Subjects

Treatments: Other: 2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters; Other: 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

NCT01574482

NU216

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 mildly hypercholesterolemic people treated or not by statins

Enrollment: 116 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• male and female aged 20-75 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 any statin monotherapy, with stabilized hypercholesterolemia (since more than 3 months), accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines), used to consume dairy products, agreeing to a written informed consent, for female: effective contraceptive methods used

Exclusion criteria

• Subject with plasma triglycerides (TG) levels > or = 350 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), smoking strictly more than 20 cigarettes/day, presenting known allergy or hypersensitivity to milk proteins, and soy, 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 the evaluation of efficiency or safety of the product , pregnant and breast feeding women

Trial design

116 participants in 2 patient groups, including a placebo group

1 = Tested product

Experimental group

Treatment:

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

2 = Control product

Placebo Comparator group

Treatment:

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