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临床试验/NCT02121457
NCT02121457已完成不适用

Effects of Brazil Nuts Consumption on Selenium Status and Cognitive Performance in Older Adults With Mild Cognitive Impairment: a Randomized Controlled Pilot Trial

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2011年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Selenium level in plasma and erythrocyte

研究概览

简要总结

Some studies reported that selenium status is associated with cognitive function. However only a few reports have investigated whether selenium supplementation can benefit cognitive performance and in most of them selenium supplementation was not exclusive. Also, none of those reports have used foods rich in selenium as a source of supplementation. Thus, the aim of our study was to investigate whether the consumption of Brazil nuts improves cognitive function. We hypothesized that the daily consumption of Brazil nuts would have benefits on selenium status, increase antioxidant enzyme activity and improve cognitive function in older adults with MCI.

详细描述

We enrolled older patients with MCI who attended the Memory and Aging Unit of the Geriatrics Division, University of São Paulo Medical School (Brazil). All participants fulfilled the criteria proposed by the International Working Group on Mild Cognitive Impairment (Winblad et al., 2004), which include the following: (1) the person is neither normal nor demented; (2) there is evidence of cognitive deterioration shown by subjective report in conjunction with objective cognitive deficits; and (3) activities of daily living are preserved and complex instrumental functions are either intact or minimally impaired. The diagnosis of MCI was based on a comprehensive neuropsychological assessment which included the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) neuropsychological battery (Welsh et al., 1994; Bertolucci et al., 2001). Participants were recruited from May 2011 to August 2012. Eligible subjects were aged 60 years or older, fluent in Portuguese, and free of any other significant neurologic or psychiatric diseases. None of them presented major depression or psychosis, had a regular intake of Brazil nuts, used supplements with selenium, or had intolerance to oleaginous food. An informed consent was obtained before the interview from all participants. The research protocol was approved by the Research Ethics Comittee of the Faculdade de Ciências Farmacêuticas da Universidade de São Paulo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •aged 60 years or older,
  • •fluent in Portuguese,
  • •free of any other significant neurologic or psychiatric diseases

排除标准

  • 未提供

研究组 & 干预措施

Control Group

No Intervention

This group did not receive any intervention.

Treatment Group

Experimental

This group took one Brazil nut daily during 6 months.

干预措施: selenium (Dietary Supplement)

Treatment Group

Experimental

This group took one Brazil nut daily during 6 months.

干预措施: Brazil nut (Dietary Supplement)

结局指标

主要结局

Selenium level in plasma and erythrocyte

时间窗: 6 months

次要结局

  • cognitive performance(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Rita Cardoso

Bárbara Rita Cardoso

University of Sao Paulo

研究点 (1)

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