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Brazil Nuts Effects on Selenium Status and Cognitive Performance

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Brazil nut
selenium
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring cognitive performance, selenium, brazil nuts, oxidative stress

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Sites / Locations

  • University Of são Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Treatment Group

Arm Description

This group did not receive any intervention.

This group took one Brazil nut daily during 6 months.

Outcomes

Primary Outcome Measures

Selenium level in plasma and erythrocyte

Secondary Outcome Measures

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

Full Information

First Posted
April 21, 2014
Last Updated
April 22, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02121457
Brief Title
Brazil Nuts Effects on Selenium Status and Cognitive Performance
Official Title
Effects of Brazil Nuts Consumption on Selenium Status and Cognitive Performance in Older Adults With Mild Cognitive Impairment: a Randomized Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
cognitive performance, selenium, brazil nuts, oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group did not receive any intervention.
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
This group took one Brazil nut daily during 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Brazil nut
Intervention Description
Participants of the treatment group were instructed to take one Brazil nut daily during 6 months. Brazil nuts were supplied in 2-month allowances at no cost together with written nutritional information and a calendar to monitor the compliance. Compliance was monitored in intervals of 2 months by checking the calendar and counting returned nuts. Compliance was considered to be adequate if ≥85% of Brazil nuts were consumed. All subjects were instructed to maintain their normal diet and to avoid additional Brazil nuts during the study.
Intervention Type
Dietary Supplement
Intervention Name(s)
selenium
Primary Outcome Measure Information:
Title
Selenium level in plasma and erythrocyte
Time Frame
6 months
Secondary Outcome Measure Information:
Title
cognitive performance
Description
Cognitive performance was measured by using six sub-testes from the CERAD neuropsychological battery have been administered to assess fundamental cognitive abilities.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Oxidative stress parameters
Description
Oxidative stress was evaluated by measuring glutathione peroxidase activity, Oxygen radical absorbance capacity (ORAC) and Malondialdehyde (MDA).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 60 years or older, fluent in Portuguese, free of any other significant neurologic or psychiatric diseases Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia F Cozzolino, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
University Of são Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05508000
Country
Brazil

12. IPD Sharing Statement

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Brazil Nuts Effects on Selenium Status and Cognitive Performance

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