Brazil Nuts Effects on Selenium Status and Cognitive Performance
Effects of Brazil Nuts Consumption on Selenium Status and Cognitive Performance in Older Adults With Mild Cognitive Impairment: a Randomized Controlled Pilot Trial
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 21, 2014
CompletedFirst Posted
Study publicly available on registry
April 23, 2014
CompletedApril 23, 2014
April 1, 2014
1.3 years
April 21, 2014
April 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Selenium level in plasma and erythrocyte
6 months
Secondary Outcomes (1)
cognitive performance
6 months
Other Outcomes (1)
Oxidative stress parameters
6 months
Study Arms (2)
Control Group
NO INTERVENTIONThis group did not receive any intervention.
Treatment Group
EXPERIMENTALThis group took one Brazil nut daily during 6 months.
Interventions
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.
Eligibility Criteria
You may qualify if:
- aged 60 years or older,
- fluent in Portuguese,
- free of any other significant neurologic or psychiatric diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Of são Paulo
São Paulo, São Paulo, 05508000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Silvia F Cozzolino, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Bárbara Rita Cardoso
Study Record Dates
First Submitted
April 21, 2014
First Posted
April 23, 2014
Study Start
May 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
April 23, 2014
Record last verified: 2014-04