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一项关于饮食补充对健康老年人认知和免疫功能影响的双盲、随机临床试验。

A double-blind, randomized clinical trial of dietary supplementation on cognitive and immune functioning in healthy older adults.

机构信息

Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Miami, FL 33136, USA.

出版信息

BMC Complement Altern Med. 2014 Feb 4;14:43. doi: 10.1186/1472-6882-14-43.

Abstract

BACKGROUND

Declining cognitive function is relatively common and increasingly prevalent. Studies have shown that different nutrients (e.g., Ginkgo biloba and vitamin E) appear to be effective at improving memory and concentration, while less is known about their effect on immunity.

METHODS

This study investigated the effect of Ginkgo Synergy(®) plus Choline (n = 33) and OPC Synergy(®) plus Catalyn(®) (n = 31) versus placebo (n = 33) in a 6-month, randomized, double-blind trial on cognitive and immune functioning among English-speaking, non-smoking, healthy older adults. The Stroop Color and Word Test, Trail Making Test A and B, Controlled Oral Word Association, Hopkins Verbal Learning, Mini-Mental State Exam, and Digit Symbol were administered at baseline and 3 and 6 months follow-up to assess cognitive functioning. Cytokines and growth factors were measured at baseline and 6 months to assess inflammation and immune functioning. Data were analyzed with linear mixed modeling.

RESULTS

No serious adverse events were noted in this study. According to time on the Trail Making Test-B, the Ginkgo Synergy(®) plus Choline arm showed improvement from baseline to 3 months follow-up (mean difference = 24.2; SE = 6.4; 95% CI: 8.6, 39.7; p = 0.01). On the Controlled Oral Word Association Trial-S, the scores significantly increased for the Ginkgo Synergy(®) plus Choline arm from baseline to 6 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 3.9; p < 0.05) and for the OPC Synergy(®) plus Catalyn(®) arm from baseline to 3 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 4.0; p < 0.05). Epidermal growth factor significantly decreased from baseline to 6 months follow-up for the Ginkgo Synergy(®) plus Choline arm (mean difference = 120.7; SE = 28.4; 95% CI: 62.6, 178.8; p < 0.001).

CONCLUSIONS

Our study showed isolated and modest effects of a Ginkgo biloba plus choline-based formula on cognitive and immune functioning among healthy older adults with no history of significant cognitive deficits. Our trial was registered with clinicaltrials.gov (ID: NCT01672359). This study was supported by a grant from Standard Process, Inc.

摘要

背景

认知功能下降较为常见且日益普遍。研究表明,不同的营养素(如银杏叶和维生素 E)似乎能有效改善记忆力和注意力,而它们对免疫功能的影响则知之甚少。

方法

本研究采用随机、双盲、对照试验,在 6 个月内,调查了银杏协同(®)加胆碱(n = 33)和 OPC 协同(®)加 Catalyn(®)(n = 31)与安慰剂(n = 33)在英语口语、不吸烟、健康老年人的认知和免疫功能方面的作用。在基线和 3 个月及 6 个月的随访中,采用 Stroop 颜色和单词测试、Trail 制作测试 A 和 B、受控口头联想测试、Hopkins 语言学习测试、简易精神状态检查和数字符号测试评估认知功能。在基线和 6 个月时测量细胞因子和生长因子,以评估炎症和免疫功能。使用线性混合模型进行数据分析。

结果

本研究未出现严重不良事件。根据 Trail 制作测试-B 的时间,银杏协同(®)加胆碱组从基线到 3 个月的随访显示出改善(平均差异= 24.2;SE = 6.4;95%CI:8.6,39.7;p = 0.01)。在受控口头联想测试-S 中,银杏协同(®)加胆碱组的分数从基线到 6 个月的随访显著增加(平均差异= 2.1;SE = 0.8;95%CI:0.2,3.9;p < 0.05),OPC 协同(®)加 Catalyn(®)组从基线到 3 个月的随访也显著增加(平均差异= 2.1;SE = 0.8;95%CI:0.2,4.0;p < 0.05)。从基线到 6 个月的随访,银杏协同(®)加胆碱组的表皮生长因子显著下降(平均差异= 120.7;SE = 28.4;95%CI:62.6,178.8;p < 0.001)。

结论

我们的研究表明,银杏叶加胆碱配方对无明显认知缺陷的健康老年人的认知和免疫功能有孤立和适度的影响。我们的试验在 clinicaltrials.gov 注册(ID:NCT01672359)。本研究由 Standard Process,Inc. 资助。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/59df/3916807/7b6f82e6885d/1472-6882-14-43-1.jpg

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