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Effects of Genetic Variations in the Response to Brazil Nut Supplementation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03111355
Acronym
SUBRANUT
Enrollment
129
Registered
2017-04-12
Start date
2013-03-01
Completion date
2016-04-19
Last updated
2018-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Supplements

Keywords

nuts, micronutrients, nutrigenomics, nutrigenetics

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 .

Interventions

DIETARY_SUPPLEMENTBrazil nut

one nut a day for 2 months, no intervention for 2 months

Sponsors

Newcastle University
CollaboratorOTHER
University of Aberdeen
CollaboratorOTHER
Aix Marseille Université
CollaboratorOTHER
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
change in Plasma Se concentrations4 weeksmeasured by ICP-MS (ug/L)
change in Plasma Glutathione Peroxidase 3 activity4 weeksmeasured by kinetic assay in a spectrometer (U/L)
change in Plasma Selenoprotein P concentrations4 weeksmeasured by ELISA (mg/dL)
change in Erythrocyte Se concentrations4 weeksmeasured by ICP-MS (ug/L)
change in Erythrocyte Glutathione Peroxidase 1 activity4 weeksmeasured by kinetic assay in an automatic spectrometer (U/gHb)

Secondary

MeasureTime frameDescription
change in total cholesterol concentration in serum4 weeksmeasured in an automatic spectrometer (mg/dL)
change in Plasma MDA concentrations (malondialdehyde)4 weeksmeasured in an automatic spectrometer (mg/dL)
change in tryglicerides concentration in serum4 weeksmeasured in an automatic spectrometer (mg/dL)
change in HDL concentration in serum4 weeksmeasured in an automatic spectrometer (mg/dL)
change in LDL concentration in serum4 weeksmeasured in an automatic spectrometer (mg/dL)
change in protein-c reactive concentration in serum4 weeksmeasured in an automatic spectrometer (mg/dL)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026