Effects of Genetic Variations in the Response to Brazil Nut Supplementation

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Genetic Variants in Selenoprotein Genes and Gender Influence Biomarkers of Se Status in Response to Brazil Nut Supplementation in Healthy Brazilians

Conditions
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Dietary Supplements

Intervention / Treatment
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* Dietary Supplement: Brazil nut


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 20 and 60 years; not taking vitamin and minerals supplements, not taking antiinflammatory, not having chronic diseases Exclusion Criteria: athletes, excessive alcohol consumption, being obese, having cancer, cardiovascular disease, diabetes and hypo or hyperthyroidism

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brazil Nut supplementation<br>Consumption of one Brazil nut a day for 2 months followed by 2 months without intervention | Dietary Supplement: Brazil nut<br>* one nut a day for 2 months, no intervention for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nuts, micronutrients, nutrigenomics, nutrigenetics