Akagi Ryota, Maruo Toshinari, Takara Tsuyoshi, Maruyama Kentaro
Innovation Center, Fujicco Co., Ltd. Kobe Hyogo Japan.
Medical Corporation Seishinkai, Takara Clinic Shinagawa-ku Tokyo Japan.
Food Sci Nutr. 2025 Jun 11;13(6):e70156. doi: 10.1002/fsn3.70156. eCollection 2025 Jun.
This study examined the effect of the intake of a test food containing black soybean seed coat extract (BE) on the sleep quality of healthy Japanese adults with poor sleep quality. This double-blind, placebo-controlled, randomized, parallel-group trial included 94 participants. We randomly assigned 64 eligible participants to either ( = 32 per group) (i) the BE group receiving a BE-containing capsule daily or (ii) the Placebo group receiving a placebo capsule daily. The primary outcome was sleepiness on rising score in the Oguri-Shirakawa-Azumi sleep inventory MA (OSA-MA) at 12 weeks after intake, and the secondary outcomes were OSA-MA, PSQI-J, original questionnaire (visual analog scale), POMS2 scores, sleep test, blood flow, palmar surface temperature, and blood test data. The final analysis included data from 64 participants. The sleepiness on rising score was significantly higher in the BE group than in the placebo group. In the BE group, sleep-onset latency and subjective dry mouth significantly decreased, and palmar surface temperature significantly increased. Furthermore, BE effectively reduced sleepiness on rising in men and increased the total sleep duration in women. For participants aged ≥ 40 years, BE improved age-related decline in sleep quality and dry mouth. Increased deep sleep and reduced sleepiness on rising were observed in those with poor sleep quality. No adverse events were reported. BE intake promoted vasodilation and increased skin temperature, decreasing the sleep-onset latency and significantly improving rising sleepiness. The mechanism is attributed to BE's antioxidant and autonomic neuromodulatory effects. UMIN-CTR: UMIN000051261.
本研究考察了摄入含有黑豆种皮提取物（BE）的试验食品对睡眠质量较差的健康日本成年人睡眠质量的影响。这项双盲、安慰剂对照、随机平行组试验纳入了94名参与者。我们将64名符合条件的参与者随机分为两组（每组n = 32）：（i）BE组，每天服用一粒含BE的胶囊；（ii）安慰剂组，每天服用一粒安慰剂胶囊。主要结局指标为摄入后12周时小暮 - 白河 - 安积睡眠量表MA（OSA - MA）中的起床时嗜睡评分，次要结局指标包括OSA - MA、PSQI - J、原始问卷（视觉模拟量表）、POMS2评分、睡眠测试、血流、手掌表面温度和血液检测数据。最终分析纳入了64名参与者的数据。BE组起床时嗜睡评分显著高于安慰剂组。在BE组中，入睡潜伏期和主观口干显著降低，手掌表面温度显著升高。此外，BE有效降低了男性起床时的嗜睡程度，增加了女性的总睡眠时间。对于年龄≥40岁的参与者，BE改善了与年龄相关的睡眠质量下降和口干症状。睡眠质量差的参与者出现了深度睡眠增加和起床时嗜睡减少的情况。未报告不良事件。摄入BE促进血管舒张并提高皮肤温度，缩短入睡潜伏期并显著改善起床时的嗜睡情况。其机制归因于BE的抗氧化和自主神经调节作用。UMIN - CTR：UMIN000051261。
