Effects of Genetic Variations in the Response to Brazil Nut Supplementation

Not Applicable

Completed

• Conditions: Dietary Supplements
• Interventions: Dietary Supplement: Brazil nut

• Registration Number: NCT03111355
• Lead Sponsor: University of Sao Paulo

Brief Summary

This study investigates the effect of genetic variations after supplementation with Brazil nuts in healthy Brazilians. Briefly, all the participants will consume one nut a day for 2 months and will stop the intake for more 2 months. Five blood sampling collection will be performed in one month interval, starting at baseline and ending at 2 months without intervention.

Detailed Description

Brazil nuts are the richest source of selenium in nature, a micronutrient that has essential functions in human physiology.

Selenium status can be measured by the quantification of biomarkers in the blood. Previous studies have shown that genetic polymorphisms can affect Se status and modulate risk for chronic diseases. In this study, five biomarkers will be quantified in the blood, before and after supplementation with Brazil nuts. The genetic variants will be used to stratify the biomarkers and multivariate linear regressions will be used to explore the influence of the polymorphisms on concentrations of the biomarkers .

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-03-01
• Primary Completion: 2014-08-15
• Study Completion: 2016-04-19
• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• age between 20 and 60 years; not taking vitamin and minerals supplements, not taking antiinflammatory, not having chronic diseases

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Exclusion Criteria

• athletes, excessive alcohol consumption, being obese, having cancer, cardiovascular disease, diabetes and hypo or hyperthyroidism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brazil Nut supplementation	Brazil nut	Consumption of one Brazil nut a day for 2 months followed by 2 months without intervention

Primary Outcome Measures

Name	Time	Method
change in Plasma Se concentrations	4 weeks	measured by ICP-MS (ug/L)
change in Plasma Glutathione Peroxidase 3 activity	4 weeks	measured by kinetic assay in a spectrometer (U/L)
change in Erythrocyte Glutathione Peroxidase 1 activity	4 weeks	measured by kinetic assay in an automatic spectrometer (U/gHb)
change in Erythrocyte Se concentrations	4 weeks	measured by ICP-MS (ug/L)
change in Plasma Selenoprotein P concentrations	4 weeks	measured by ELISA (mg/dL)

Secondary Outcome Measures

Name	Time	Method
change in total cholesterol concentration in serum	4 weeks	measured in an automatic spectrometer (mg/dL)
change in HDL concentration in serum	4 weeks	measured in an automatic spectrometer (mg/dL)
change in LDL concentration in serum	4 weeks	measured in an automatic spectrometer (mg/dL)
change in protein-c reactive concentration in serum	4 weeks	measured in an automatic spectrometer (mg/dL)
change in Plasma MDA concentrations (malondialdehyde)	4 weeks	measured in an automatic spectrometer (mg/dL)
change in tryglicerides concentration in serum	4 weeks	measured in an automatic spectrometer (mg/dL)