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

A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects

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.

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