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六个月小飞扬草提取物补充剂对轻度认知障碍老年人的影响:一项双盲、随机、安慰剂对照试验。

The effects of six months Persicaria minor extract supplement among older adults with mild cognitive impairment: a double-blinded, randomized, and placebo-controlled trial.

机构信息

Center for Healthy Aging and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur, Malaysia.

Centre for Diagnostic and Applied Sciences, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300, Kuala Lumpur, Malaysia.

出版信息

BMC Complement Med Ther. 2020 Oct 19;20(1):315. doi: 10.1186/s12906-020-03092-2.

Abstract

BACKGROUND

Persicaria minor extract exhibits antioxidant and anti-inflammatory properties and has potential effects on cognitive function and mood. However, the effects of P.minor on brain activation and biomarkers have not been studied among older adults. This multicentre, randomized, double-blinded, placebo-controlled study aimed to investigate the effect of 6 months P.minor extract supplement (Biokesum®) on cognition, mood, biomarkers, and brain activation among older adults with Mild Cognitive Impairment (MCI).

METHOD

A total of 36 Malaysian community-dwelling older adults with MCI (60-75-year-old) were randomized into Biokesum® (n = 18) and placebo group (n = 18). Each subject consumed one capsule of Biokesum® (250 mg/capsule) or placebo (maltodextrin, 280 mg/capsule) twice daily for 6 months. Cognitive function and mood were assessed at baseline, 3rd, and 6th-month using neuropsychological tests (MMSE, Digit Span, RAVLT, Digit Symbol, and Visual Reproduction) and Profile of Mood State (POMS) questionnaire. Blood lipid profile, fasting blood glucose, and biomarkers (MDA, LPO, COX-2, iNOS, and BDNF) were measured at baseline and 6th month. By the end of the intervention, there were 30 compliers (Biokesum®: N = 15; Placebo: N = 15) and 6 dropouts. For brain activation assessment, 15 subsamples (Biokesum®: N = 8; Placebo: N = 7) completed N-back and Stroop tasks during fMRI scanning at baseline and 6th month. The dorsolateral prefrontal cortex (Brodmann's area 9 and 46) was identified as a region of interest (ROI) for brain activation analysis using SPM software.

RESULTS

Two-way mixed ANOVA analysis showed significant improvements in Visual Reproduction II (p = 0.012, partial η = 0.470), tension (p = 0.042, partial η = 0.147), anger (p = 0.010, partial η = 0.207), confusion (p = 0.041, partial η = 0.148), total negative subscales (p = 0.043, partial η = 0.145), BDNF (p = 0.020, partial η = 0.179) and triglyceride (p = 0.029, partial η = 0.237) following 6 months of Biokesum® supplementation. Preliminary finding also demonstrated significant improvement at 0-back task-induced right DLPFC activation (p = 0.028, partial η = 0.652) among subsamples in Biokesum® group. No adverse events were reported at the end of the study.

CONCLUSION

Six months Biokesum® supplementation potentially improved visual memory, negative mood, BDNF, and triglyceride levels among older adults with MCI. Significant findings on brain activation at the right DPLFC must be considered as preliminary.

TRIAL REGISTRATION

Retrospectively registered on 30th August 2019 [ ISRC TN12417552 ].

摘要

背景

小藜提取物具有抗氧化和抗炎特性,对认知功能和情绪有潜在影响。然而,其对老年人大脑激活和生物标志物的影响尚未得到研究。本多中心、随机、双盲、安慰剂对照研究旨在探讨 6 个月小藜提取物补充剂(Biokesum®)对轻度认知障碍(MCI)老年人认知、情绪、生物标志物和大脑激活的影响。

方法

共纳入 36 名马来西亚社区居住的 MCI 老年人(60-75 岁),随机分为 Biokesum®组(n=18)和安慰剂组(n=18)。每位受试者每天口服 Biokesum®(250mg/胶囊)或安慰剂(麦芽糊精,280mg/胶囊)两次,持续 6 个月。在基线、第 3 个月和第 6 个月使用神经心理学测试(MMSE、数字跨度、RAVLT、数字符号和视觉再现)和心境状态问卷(POMS)评估认知功能和情绪。在基线和第 6 个月测量血脂谱、空腹血糖和生物标志物(MDA、LPO、COX-2、iNOS 和 BDNF)。干预结束时,有 30 名依从者(Biokesum®:N=15;安慰剂:N=15)和 6 名脱落者。对于大脑激活评估,15 名亚组(Biokesum®:N=8;安慰剂:N=7)在基线和第 6 个月的 fMRI 扫描期间完成 N-back 和 Stroop 任务。使用 SPM 软件,将额外侧前额皮质(Brodmann 区 9 和 46)确定为大脑激活分析的感兴趣区域(ROI)。

结果

双向混合方差分析显示,视觉再现 II(p=0.012,部分 η=0.470)、紧张(p=0.042,部分 η=0.147)、愤怒(p=0.010,部分 η=0.207)、困惑(p=0.041,部分 η=0.148)、总负性亚量表(p=0.043,部分 η=0.145)、BDNF(p=0.020,部分 η=0.179)和甘油三酯(p=0.029,部分 η=0.237)在 Biokesum®补充 6 个月后有显著改善。初步结果还表明,Biokesum®组的右背外侧前额叶皮质(DLPFC)在 0 回任务诱导的大脑激活方面有显著改善(p=0.028,部分 η=0.652)。研究结束时未报告不良事件。

结论

Biokesum®补充 6 个月可能改善 MCI 老年人的视觉记忆、负面情绪、BDNF 和甘油三酯水平。右 DPLFC 大脑激活的显著发现必须被视为初步结果。

试验注册

2019 年 8 月 30 日回顾性注册[ISRC TN12417552]。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ff5/7574246/f436f4ebdd0d/12906_2020_3092_Fig1_HTML.jpg

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