Previous reports showed that oral administration of Leuconostoc mesenteroides strain NTM048 increases IgA levels and CD4+ T cell population in feces and mice, respectively, as revealed by flow cytometric analysis of splenocytes. This study aimed to evaluate the effect of chocolate supplemented with L. mesenteroides strain NTM048 (> 1.00 × 109 CFU/day, NTM048) on the immune parameters of healthy subjects, using a randomized, placebo-controlled, double-blinded study design. Participants (mean age: 46.3 years) ingested 28 g of test food daily, at a time of their own choice, for 4 weeks. The immunological parameters of all participants were evaluated two times (pre- and post- ingestion). At the end of the study, various immunological parameters of the participants were measured and scoring of immunological vigor (SIV) was performed using a comprehensive algorithm. Ingestion of NTM048-supplemented chocolate significantly improved SIV in the NTM048 group (18.6 ± 1.6) compared to that in the placebo group (17.8 ± 2.0) after 4 weeks (p = 0.049). Several immunological parameters (CD8+T cells, CD8+CD28+ T cells, and memory T cells) were significantly elevated in the NTM048 group as compared to the placebo group (all p < 0.05). In addition, T cell proliferation index at post-ingestion significantly increased compared with that at pre-ingestion in the NTM048 (p = 0.017) and placebo groups (p = 0.037), although no differences were observed between the two groups. Our results suggest that ingestion of chocolate supplemented with NTM048 is effective against the age-related decline in T cell-related immune functions. UMIN Clinical Trials Registry UMIN000021989. Registered 19 April 2016, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025321

中文翻译：

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含有肠系膜明串珠菌 NTM048 菌株的巧克力对免疫功能的影响：一项随机、双盲、安慰剂对照试验

先前的报道表明，通过脾细胞的流式细胞术分析显示，口服肠系膜明串珠菌菌株 NTM048 可分别增加粪便和小鼠中的 IgA 水平和 CD4+ T 细胞群。本研究旨在使用随机、安慰剂对照、双盲研究设计，评估添加肠系膜乳杆菌菌株 NTM048（> 1.00 × 109 CFU/天，NTM048）的巧克力对健康受试者免疫参数的影响。参与者（平均年龄：46.3 岁）每天在他们自己选择的时间摄入 28 克测试食物，持续 4 周。对所有参与者的免疫学参数进行了两次评估（摄入前和摄入后）。在研究结束时，测量参与者的各种免疫学参数，并使用综合算法进行免疫活力（SIV）评分。4 周后，与安慰剂组 (17.8 ± 2.0) 相比，NTM048 组 (18.6 ± 1.6) 的摄入 NTM048 补充巧克力显着改善了 SIV (p = 0.049)。与安慰剂组相比，NTM048 组的一些免疫学参数（CD8+T 细胞、CD8+CD28+ T 细胞和记忆 T 细胞）显着升高（所有 p < 0.05）。此外，与摄入前相比，NTM048 (p = 0.017) 和安慰剂组 (p = 0.037) 摄入后的 T 细胞增殖指数显着增加，尽管两组之间没有观察到差异。我们的研究结果表明，摄入含有 NTM048 的巧克力可有效对抗与年龄相关的 T 细胞相关免疫功能下降。UMIN 临床试验登记处 UMIN000021989。2016 年 4 月 19 日注册，https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025321