Effects of Fermented Milk Product Enriched With Plant Sterols and Policosanols in Mild Hypercholesterolaemic Adults

Danone

Status: Completed

Conditions: Mildly Hypercholesterolemic Subjects

Treatments: Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit; Other: 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control); Other: 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit

Study type: Interventional

Funder types: Industry

Identifiers

NCT01571882

NU235

Details and patient eligibility

About

The objective of this study is to investigate the effect of consumption of a low-fat, no added sugar, dairy fermented product enriched with plant sterols and policosanols at two doses, on LDL-cholesterol concentration in hypercholesterolaemic adults after 3 weeks of product consumption versus active control product.

Enrollment: 72 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 and 190 mg/dL (bounds included) stabilized for more than 3 months,
• without statin monotherapy or other hypocholesterolaemic drug treatment,
• accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines)

Exclusion criteria

• serum triglyceride (TG) levels ≥ 4 mmol/L (3.5 g/L), having experienced any cardiovascular event in the last 6 months,
• receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters

Trial design

72 participants in 3 patient groups

1 = Tested product 1

Experimental group

Treatment:

Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit

2 = tested product 2

Experimental group

Treatment:

Other: 2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit

3 = Active control product

Active Comparator group

Treatment:

Other: 3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)