Brazil Nuts Effects on Selenium Status and Cognitive Performance
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|ClinicalTrials.gov Identifier: NCT02121457|
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : April 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Dietary Supplement: Brazil nut Dietary Supplement: selenium||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
No Intervention: Control Group
This group did not receive any intervention.
Experimental: Treatment Group
This group took one Brazil nut daily during 6 months.
Dietary Supplement: Brazil nut
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.
Dietary Supplement: selenium
- Selenium level in plasma and erythrocyte [ Time Frame: 6 months ]
- cognitive performance [ Time Frame: 6 months ]Cognitive performance was measured by using six sub-testes from the CERAD neuropsychological battery have been administered to assess fundamental cognitive abilities.
- Oxidative stress parameters [ Time Frame: 6 months ]Oxidative stress was evaluated by measuring glutathione peroxidase activity, Oxygen radical absorbance capacity (ORAC) and Malondialdehyde (MDA).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121457
|University Of são Paulo|
|São Paulo, SP, Brazil, 05508000|
|Study Director:||Silvia F Cozzolino, PhD||University of São Paulo|