Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans

Naturalis Clinical Trial for a Novel Phytosterol Formulation

The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products.

Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.

Inclusion Criteria:

• healthy individuals aged 19-60 yr
• plasma LDL-C levels > 3.0mmol/l
• TG < 4.5mmol/l
• body mass index (BMI) between 20 and 30 kg/m2.

Exclusion Criteria:

• history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
• history of chronic use of alcohol (>2 drinks/d)
• smoking
• myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months