Lipid Clinic at the Interdisciplinary Metabolism Center and Department of Geriatrics, Charité University Medicine, 13353 Berlin, Germany.
J Dairy Sci. 2011 Feb;94(2):589-601. doi: 10.3168/jds.2010-3115.
Malleable protein matrix (MPM) is a unique whey-derived ingredient obtained through a fermentation process using proprietary lactic acid bacteria strains from the Lactobacillus kefiranofaciens species. Because evidence from animal models suggests that MPM decreases serum lipid concentrations, the purpose of the present trial was to assess the hypothesis that MPM exerts lipid-lowering effects in humans. A total of 161 subjects (50% male; age 54.5 ± 9.8 yr, body mass index 26.3 ± 3.6 kg/m(2)) with hypercholesterolemia with baseline low-density lipoprotein cholesterol (LDL-C) levels of 181 ± 30 mg/dL and normal triglyceride (TG) levels (131 ± 55 mg/dL) were randomized to receive MPM (2 × 15 g/d) or matching placebo. A 6-wk run-in phase was followed by a double-blind 12-wk treatment phase after randomization. The data were analyzed on an intention-to-treat basis. The primary outcome measure was the percentage change of LDL-C. The secondary outcome measures were changes in TG and high-density lipoprotein cholesterol concentrations as well as changes in other cardiovascular risk factors. After 12 wk of treatment, the relative TG decrease from baseline reached 9.8%, whereas LDL-C was slightly decreased (by 1.5%) following MPM treatment compared with placebo in the intention-to-treat cohort. The treatment effect on TG reduction was much higher in the subset of subjects having TG levels at baseline of 150 mg/dL or above (n=42), reaching 20.0% compared with placebo. High-density lipoprotein cholesterol concentrations, blood pressure, and fasting blood glucose remained unchanged, whereas a positive treatment effect was seen on hemoglobin A(1c). The MPM product was tolerated well without severe adverse events. In conclusion, MPM has significant TG-lowering properties in subjects with combined hypercholesterolemia and higher TG levels. Its effects on LDL-C concentrations and glucose metabolism deserve further investigation.
可变形蛋白质基质（MPM）是一种独特的乳清衍生成分，通过使用来自 Lactobacillus kefiranofaciens 物种的专有乳酸菌菌株的发酵过程获得。由于动物模型的证据表明 MPM 可降低血清脂质浓度，因此本试验旨在评估 MPM 对人体具有降低血脂作用的假设。共有 161 名受试者（50%为男性；年龄 54.5 ± 9.8 岁，体重指数 26.3 ± 3.6 kg/m²）患有高胆固醇血症，基线低密度脂蛋白胆固醇（LDL-C）水平为 181 ± 30 mg/dL，正常甘油三酯（TG）水平（131 ± 55 mg/dL），随机分为 MPM（2×15 g/d）或匹配的安慰剂组。在随机分组后，进行了 6 周的导入期，然后进行了 12 周的双盲治疗期。数据分析采用意向治疗原则。主要终点测量指标是 LDL-C 的百分比变化。次要终点测量指标是 TG 和高密度脂蛋白胆固醇浓度的变化以及其他心血管危险因素的变化。经过 12 周的治疗，与安慰剂相比，MPM 治疗组的相对 TG 从基线降低了 9.8%，而 LDL-C 略有降低（1.5%）。在基线 TG 水平为 150 mg/dL 或以上的受试者亚组中（n=42），治疗对 TG 降低的效果更高，达到 20.0%，与安慰剂相比。高密度脂蛋白胆固醇浓度、血压和空腹血糖保持不变，而血红蛋白 A1c 则出现阳性治疗效果。MPM 产品耐受性良好，无严重不良事件。总之，MPM 对同时患有高胆固醇血症和更高 TG 水平的受试者具有显著的 TG 降低作用。其对 LDL-C 浓度和葡萄糖代谢的影响值得进一步研究。
