Genetic Variants in Selenoprotein Genes and Gender Influence Biomarkers of Se Status in Response to Brazil Nut Supplementation in Healthy Brazilians
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 129
- Primary Endpoint
- change in Plasma Se concentrations
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Brazil Nut supplementation
Consumption of one Brazil nut a day for 2 months followed by 2 months without intervention
Intervention: Brazil nut (Dietary Supplement)
Outcomes
Primary Outcomes
change in Plasma Se concentrations
Time Frame: 4 weeks
measured by ICP-MS (ug/L)
change in Plasma Glutathione Peroxidase 3 activity
Time Frame: 4 weeks
measured by kinetic assay in a spectrometer (U/L)
change in Erythrocyte Glutathione Peroxidase 1 activity
Time Frame: 4 weeks
measured by kinetic assay in an automatic spectrometer (U/gHb)
change in Erythrocyte Se concentrations
Time Frame: 4 weeks
measured by ICP-MS (ug/L)
change in Plasma Selenoprotein P concentrations
Time Frame: 4 weeks
measured by ELISA (mg/dL)
Secondary Outcomes
- change in total cholesterol concentration in serum(4 weeks)
- change in HDL concentration in serum(4 weeks)
- change in LDL concentration in serum(4 weeks)
- change in protein-c reactive concentration in serum(4 weeks)
- change in Plasma MDA concentrations (malondialdehyde)(4 weeks)
- change in tryglicerides concentration in serum(4 weeks)
Investigators
Janaina Donadio
Principal Investigator
University of Sao Paulo