Guangdong Provincial Key Laboratory of Food, Nutrition and Health, and Department of Nutrition, School of Public Health, Sun Yat-sen University, China.
Department of Statistics and Epidemiology, School of Public Health, Sun Yat-sen University, China.
Clin Nutr. 2023 Sep;42(9):1637-1646. doi: 10.1016/j.clnu.2023.07.017. Epub 2023 Jul 21.
BACKGROUND & AIMS: Modulating microbial metabolism via probiotic supplementation has been proposed as an attractive strategy for the prevention of cardiometabolic diseases. Recently, Lacticaseibacillus paracasei (L. paracasei) was reported to alleviate metabolic disorders in murine models, however, its beneficial effects in humans remain to be determined. This study evaluated whether L. paracasei supplementation could improve endothelial function and cardiometabolic health in subjects with metabolic syndrome (MetS).
In this randomized, double-blind and placebo-controlled trial among 130 participants with MetS, subjects were randomly assigned to placebo or L. paracasei 8700: 2 (10 billion CFU) daily for 12 weeks. Endothelial function was measured by flow-mediated slowing, and cardiometabolic health was determined by both components and severity of MetS. Ideal compliance was defined as consumption no less than 70% of the capsules.
130 individuals (mean [SD] age, 45.97 [7.11] years; 95 men [73.1%]) were enrolled and randomized to L. paracasei (n = 66) or placebo control (n = 64). Compared to placebo, L. paracasei supplementation led to a greater reduction in remnant cholesterol (-0.16 mmol/L, 95%CI: -0.29 mmol/L to -0.02 mmol/L; P = 0.024). Such a reduction in remnant cholesterol was significantly associated with improvement in endothelial function (r = -0.23, P = 0.027). In subjects with an ideal compliance with trial protocol, L. paracasei treatment additionally lowered triglycerides, alleviated MetS severity and delayed weight gain. On the contrary, no obvious effect on insulin sensitivity or pancreatic beta-cell function was observed after L. paracasei intervention. Moreover, regarding safety and tolerability, no significant between-group difference in protocol-specified adverse events of interest was observed.
L. paracasei supplementation enhanced endothelial function potentially through downregulating remnant cholesterol levels. Our study provides a feasible and safe strategy for the prevention of cardiometabolic diseases in subjects with severe dyslipidemia and endothelial dysfunction.
Under ClinicalTrails.gov identifier NCT05005754.
通过益生菌补充来调节微生物代谢，已被提出作为预防心脏代谢疾病的一种有吸引力的策略。最近，有研究报道鼠李糖乳杆菌（L. paracasei）可减轻代谢综合征（MetS）动物模型中的代谢紊乱，但它在人类中的有益作用仍有待确定。本研究评估了 L. paracasei 补充是否可以改善 MetS 患者的内皮功能和心脏代谢健康。
在这项针对 130 名 MetS 患者的随机、双盲、安慰剂对照试验中，受试者被随机分配至安慰剂或 L. paracasei 8700:2（100 亿 CFU）每日一次，持续 12 周。通过血流介导的舒张来测量内皮功能，通过 MetS 的组成部分和严重程度来确定心脏代谢健康。理想的依从性定义为胶囊摄入量不少于 70%。
共纳入 130 名个体（平均[标准差]年龄为 45.97[7.11]岁；95 名男性[73.1%]），并随机分为 L. paracasei（n=66）或安慰剂对照组（n=64）。与安慰剂相比，L. paracasei 补充治疗可使残余胆固醇降低更多（-0.16mmol/L，95%置信区间：-0.29mmol/L 至-0.02mmol/L；P=0.024）。残余胆固醇的这种降低与内皮功能的改善显著相关（r=-0.23，P=0.027）。在遵守试验方案的理想依从性的受试者中，L. paracasei 治疗还可降低甘油三酯，减轻 MetS 严重程度并延迟体重增加。相反，L. paracasei 干预后胰岛素敏感性或胰岛β细胞功能无明显变化。此外，关于安全性和耐受性，未观察到两组间有意义的协议规定的不良事件差异。
L. paracasei 补充可通过降低残余胆固醇水平来增强内皮功能。本研究为预防严重血脂异常和内皮功能障碍的 MetS 患者的心脏代谢疾病提供了一种可行且安全的策略。
在 ClinicalTrails.gov 标识符 NCT05005754 下注册。
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