Brazil Nuts Effects on Selenium Status and Cognitive Performance

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Dietary Supplement: Brazil nut; Dietary Supplement: selenium

• Registration Number: NCT02121457
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-04
• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-04-22
• Last Update Submitted: 2014-04-22
• Study First Posted: 2014-04-23
• Last Update Posted: 2014-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Brazil nut	This group took one Brazil nut daily during 6 months.
Treatment Group	selenium	This group took one Brazil nut daily during 6 months.

Primary Outcome Measures

Name	Time	Method
Selenium level in plasma and erythrocyte	6 months

Secondary Outcome Measures

Name	Time	Method
cognitive performance	6 months	Cognitive performance was measured by using six sub-testes from the CERAD neuropsychological battery have been administered to assess fundamental cognitive abilities.

Trial Locations

Locations (1)

University Of são Paulo; 🇧🇷 São Paulo, SP, Brazil