Sun Jianqin, Xu Danfeng, Xie Hua, Wang Yan, Chen Min, Chang Xifeng, Pan Yiru, Liu Yuan, Xue Huijun, Zhao Hu, Chen Yanqiu, Xiao Fei
Center of Clinical Nutrition, Fudan University Affiliated Huadong Hospital, Shanghai 200040, China. Email:
Zhonghua Xin Xue Guan Bing Za Zhi. 2014 Jul;42(7):588-92.
To observe the impact of plant sterol esters (PSE) mixed in low fat milk powder (2.5 g of PSE/day) on plasma cholesterol levels in hypercholesterolemic subjects during a 6-week intervention period.
In this double-blind, randomized, placebo-controlled study, 59 subjects (19 males, mean age (60.28 ± 6.98) years) with primary hypercholesterolemia (fasting LDL cholesterol between 3.4-6.0 mmol/L) were randomly divided into two groups (treatment group, 2.5 g of plant sterol esters a day, n = 30) and placebo group (n = 29). Blood samples were collected at week 0, 3 and 6. The primary outcome was change in plasma LDL-cholesterol (LDL-C). Secondary outcomes were changes in total cholesterol (TC), HDL cholesterol (HDL-C), triglycerides (TG), anthropometry and blood biochemistry.
LDL-C significantly reduction from baseline (4.18 ± 0.54) mmol/L to (3.44 ± 0.61) mmol/L (-17.7%, P < 0.05) at week 3 and (3.35 ± 0.39) mmol/L (-19.9%, P < 0.05) at week 6 in the treatment group, whereas in placebo group from (4.11 ± 0.54) mmol/L at baseline to (3.47 ± 0.60) mmol/L (-15.57%, P < 0.05) and (3.61 ± 0.39) mmol/L (-12.17%, P < 0.05) at week 3 and week 6, respectively. TC was reduced from (6.30 ± 0.86) mmol/L at baseline to (5.92 ± 0.75) mmol/L (-6.03%, P > 0.05) at week 3 and (5.43 ± 0.77) mmol/L (-13.8%, P < 0.05) at week 6 in treatment group, from (6.20 ± 0.76) mmol/L at week 0 to (5.70 ± 0.76) mmol/L (-8.06%, P < 0.05) at week 3 and (5.84 ± 0.75) mmol/L (-5.81%, P < 0.05) at week 6 in placebo group. PSE-enriched milk did not affect plasma HDL-C level and TG level at both week 3 and week 6. After normalization to the placebo group, the treatment group showed significant reduction in LDL-C and total cholesteron after 6 weeks. The observed difference of reduction was 7.69% (-0.33 mmol/L, P < 0.05) for LDL-C and 8.00% (-0.51 mmol/L, P < 0.05) for TC between the two groups. There were no significant changes in safety parameters, including blood biochemistry tests during the study period.
Plant sterol ester enriched milk powder is effective in reducing LDL-C among Chinese hypercholesterolemic subjects at a dosage recommended by EFSA.
观察低脂奶粉中添加植物甾醇酯（PSE，每天2.5克）对高胆固醇血症患者在6周干预期内血浆胆固醇水平的影响。
在这项双盲、随机、安慰剂对照研究中，59例原发性高胆固醇血症患者（19例男性，平均年龄(60.28±6.98)岁，空腹低密度脂蛋白胆固醇在3.4 - 6.0 mmol/L之间）被随机分为两组（治疗组，每天2.5克植物甾醇酯，n = 30）和安慰剂组（n = 29）。在第0、3和6周采集血样。主要观察指标是血浆低密度脂蛋白胆固醇（LDL-C）的变化。次要观察指标包括总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）、甘油三酯（TG）、人体测量指标和血液生化指标的变化。
治疗组在第3周时，LDL-C从基线水平(4.18±0.54) mmol/L显著降至(3.44±0.61) mmol/L（降低17.7%，P < 0.05），在第6周时降至(3.35±0.39) mmol/L（降低19.9%，P < 0.05）；而安慰剂组在第3周时从基线水平(4.11±0.54) mmol/L降至(3.47±0.60) mmol/L（降低15.57%，P < 0.05），在第6周时降至(3.61±0.39) mmol/L（降低12.17%，P < 0.05）。治疗组TC在第3周时从基线水平(6.30±0.86) mmol/L降至(5.92±0.75) mmol/L（降低6.03%，P > 0.05），在第6周时降至(5.43±0.77) mmol/L（降低13.8%，P < 0.05）；安慰剂组在第0周时为(6.20±0.76) mmol/L，第3周时降至(5.70±0.76) mmol/L（降低8.06%，P < 0.05），第6周时降至(5.84±0.75) mmol/L（降低5.81%，P < 0.05）。富含PSE的牛奶在第3周和第6周时均未影响血浆HDL-C水平和TG水平。与安慰剂组校正后，治疗组在6周后LDL-C和总胆固醇显著降低。两组间LDL-C降低的观察差异为7.69%（-0.33 mmol/L，P < 0.05），TC为8.00%（-0.51 mmol/L，P < 0.05）。在研究期间，包括血液生化检查在内的安全性参数没有显著变化。
在欧洲食品安全局（EFSA）推荐的剂量下，富含植物甾醇酯的奶粉对降低中国高胆固醇血症患者的LDL-C有效。
