The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human

In a randomized, placebo-controlled double-blind mono-centric study,179 subjects with total cholesterol (TC) level above 5.18mmol/L and triglyceride (TG) level lower than 2.25mmol/L were assigned to 500ml of low lactose milk enriched with 1.58g plant sterol esters or 500ml plain milk without plant sterols (placebo) or without any dairy product consumption (control) for 60 days. Subjects were instructed to maintain stable diet pattern and physical activity. Plasma concentrations of TC,TG,LDL cholesterol(LDL-C) and HDL cholesterol(HDL-C) were measured at initial visits, after 30days and after 60 days. The primary measurement was the change in TC. Secondary measurements were changes in TG,LDL-C and HDL-C.

Inclusion criteria

• Male or female subjects, 18-65 yrs;
• Serum TC ≥5.18mmol/L, and TG≤2.25mmol/L;
• Normal blood pressure or able to control blood pressure within normal range;
• Willing to consent to study participation and to comply with study requirements.

Exclusion criteria

• Pregnant or breastfeeding women;
• Known allergies to dairy and any substance in the study product.For example lactose intolerance;
• Any comorbidity that could,in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes, including but not limited to cardiac disease, hepatic disease, renal disease, hematopoietic system disease and mental disease;
• Recent use (within 2 weeks of screening) of any prescription or OTC medication that affects serum total cholesterol or that may confound study outcomes.