Effect of milk enriched with phytosterol ester on blood cholesterol of patients with hypercholesterolemia: a randomized controlled trial

OBJECTIVE: To study the effect of milk enriched with phytosterol ester on blood cholesterol. METHODS: Participants with hypercholesterolemia were recruited from community health center and randomly assigned to 3 groups: milk enriched with phytosterol ester group( PS group, n = 59), normal milk group( n = 58) and non-dairy group( n = 62). The intervention lasted for 2 months. At baseline, all subjects in the 3groups received health education on prevention and control of hypercholesterolemia. For PS and normal milk groups, subjects consumed 500 g milk per day, the intake ofphytosterol in PS group was 1. 58 g / d. For non-dairy group, subjects did not consume any dairy products during the trial. Subjects were assessed on their physical activity level and blood cholesterols were measured during monthly follow-up. RESULTS: Finally 157 subjects completed the trial. By the end of the first month, the TC and LDL-C levels of PS group were significantly lower than that of normal milk group. After adjustment, there was no significant difference between baseline and 1-month TC levels in PS group. The levels of TG and HDL-C in PS group were significantly increased while the LDL-C level was significantly decreased after 1-month intervention. Compared with normal milk and nondairy groups, no differences were observed for these four indicators. After 2-month intervention, the TC and LDL-C levels of PS group were significantly lower than that of normal milk and non-dairy groups. The levels of TC and LDL-C in PS group were significantly reduced compared to baseline levels after adjustment. TG level was increased while HDL-C level was unchanged. Compared with normal milk and non-dairy groups, the levels of TC and LDL-C in PS group were significantly declined while no significant difference was observed for TG and HDL-C levels. CONCLUSION: s Milk enriched with phytosterol ester has a notable effect on lowering TC and LDL-C levels in subjects with hypercholesterolemia.