The prevalence of cognitive impairment in multiple sclerosis (MS) patients is estimated to be approximately 40–60%. There is an increasing body of evidence regarding the impact of both selenium and crocin as antioxidant agents on cognitive function. In the present study, for the first time, we investigated the effect of crocin-selenium nanoparticles (Cor@SeNs) on cognitive function and oxidative stress markers in MS patients. A triple-blind randomized clinical trial was conducted among 60 MS patients. The participants were randomly divided in a 1:1 ratio to either the Cor@SeNs or placebo group, employing block randomization. During the course of 12 weeks, the participants received Cor@SeNs capsules, containing 5.74 mg crocin and 55 mcg Selenium, or placebo capsules. Cognition assessed using the Persian version of the Brief International Cognitive Assessment for MS (BICAMS) battery. Serum levels of total antioxidant capacity (TAC), glutathione reductase (GR) activity and malondialdehyde (MDA) determined by colorimetric kits. Data analysis was performed in SPSS, version 26. P < 0.05 was considered as the significant range. The mean ± SD of TAC change was 0.03 ± 0.07 mM vs. − 0.03 ± 0.09 mM in intervention and placebo groups, respectively (Time × group effect P: 0.01; effect size: 0.10). The time effect of intervention on the California Verbal Learning Test second edition (CVLT-II) (P < 0.01; effect size: 0.29), CVLT-II-delay (P < 0.01; effect size: 0.29), and the Symbol Digit Modalities Test (SDMT) (P < 0.01; effect size: 0.18) was increasing and significant. In addition, the time effect of intervention on GR activity was significant and decreasing in both groups (P < 0.01; effect size: 0.20). Our results suggested a significant effect of the Cor@SeNs intervention in improving TAC. We also observed a significant improvement in cognitive function in both groups during our study. However, although not statistically significant, a higher amount of change in cognitive function and serum antioxidant markers was noted in the Cor@SeNs group compared to the placebo group. This is the first study on this nano product with low dose of selenium and crocin. More investigations with longer duration and varied doses are suggested.

多发性硬化症 (MS) 患者认知障碍的患病率估计约为 40-60%。越来越多的证据表明硒和藏红花素作为抗氧化剂对认知功能的影响。在本研究中，我们首次研究了藏红花素硒纳米颗粒（Cor@SeNs）对多发性硬化症患者认知功能和氧化应激标志物的影响。在 60 名多发性硬化症患者中进行了一项三盲随机临床试验。采用分组随机化，参与者以 1:1 的比例随机分为 Cor@SeNs 组或安慰剂组。在 12 周的过程中，参与者服用了 Cor@SeNs 胶囊，其中含有 5.74 毫克藏红花素和 55 微克硒，或安慰剂胶囊。使用波斯语版本的 MS 简短国际认知评估 (BICAMS) 电池进行认知评估。通过比色试剂盒测定总抗氧化能力 (TAC)、谷胱甘肽还原酶 (GR) 活性和丙二醛 (MDA) 的血清水平。数据分析在SPSS 26版中进行。P < 0.05被认为是显着范围。干预组和安慰剂组 TAC 变化的平均值±标准差分别为 0.03 ± 0.07 mM 与 − 0.03 ± 0.09 mM（时间 × 组效应 P：0.01；效应大小：0.10）。加州言语学习测试第二版 (CVLT-II) 干预的时间效应（P < 0.01；效应大小：0.29）、CVLT-II 延迟（P < 0.01；效应大小：0.29）和符号数字模态测试 (SDMT)（P < 0.01；效应大小：0.18）不断增加且显着。此外，干预对 GR 活动的时间效应显着，并且在两组中均呈下降趋势（P < 0.01；效应大小：0.20）。我们的结果表明 Cor@SeNs 干预对改善 TAC 具有显着效果。在我们的研究过程中，我们还观察到两组的认知功能都有显着改善。然而，虽然没有统计学意义，但与安慰剂组相比，Cor@SeNs 组的认知功能和血清抗氧化标志物的变化量更大。这是对这种含有低剂量硒和藏红花素的纳米产品的首次研究。建议进行更多、更长持续时间和不同剂量的研究。