Randomised controlled trial of the effect of phytosterol-enriched low-fat milk on lipid profile in Chinese

Abstract

OBJECTIVE: Phytosterols found naturally in plants are known to reduce cholesterol absorption in the gut. The Chinese diet typically contains many vegetables and not much meat; we therefore aimed to test if phytosterols are as effective in Chinese. METHOD: There were 221 (41 men, 180 women; age 24-79) subjects who consented to participate in the study (ClinicalTrials.gov ID: NCT02541201), the protocol of which was approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster. Subjects were randomised to double-blind intake of a phytosterol-enriched low-fat milk or a conventional low-fat milk for three weeks. Before every breakfast and lunch, they had a 273 ml serving. Active treatment contained 1.5 g/day phytosterol. Fasting blood samples for lipid profile were taken before and at the end of study. Body weight, waist circumference and blood pressure were also measured. RESULTS: LDL-cholesterol decreased from 3.22±0.08 to 3.06±0.08 mmol/L in the phytosterol group and increased from 3.08±0.08 to 3.20±0.08 mmol/L in controls. Comparing treatment with control, the decrease in LDL-cholesterol was 9.5±2.0% (p<0.001). There were no significant changes in HDL-cholesterol, triglycerides, body weight or blood pressure. Five subjects (2.3%; 4 in treatment group) withdrew. CONCLUSION: Consumption of a phytosterol-enriched low-fat milk led to a significant fall in LDL-cholesterol. This can be recommended as part of a healthy diet for people with mildly elevated cholesterol levels and not at high cardiovascular risk. Statins and ezetimibe remain the treatment of choice for those with high cholesterol levels or high cardiovascular risk.