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Completed

NCT Number: NCT03111355

Effects of Genetic Variations in the Response to Brazil Nut Supplementation

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.

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Key information

Conditions

Dietary Supplements

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brazil Nut

Dietary Supplement

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

Primary outcomes

  1. change in Plasma Se concentrations

    Time frame: 4 weeks

    measured by ICP-MS (ug/L)

  2. change in Plasma Glutathione Peroxidase 3 activity

    Time frame: 4 weeks

    measured by kinetic assay in a spectrometer (U/L)

  3. change in Plasma Selenoprotein P concentrations

    Time frame: 4 weeks

    measured by ELISA (mg/dL)

  4. change in Erythrocyte Se concentrations

    Time frame: 4 weeks

    measured by ICP-MS (ug/L)

  5. change in Erythrocyte Glutathione Peroxidase 1 activity

    Time frame: 4 weeks

    measured by kinetic assay in an automatic spectrometer (U/gHb)

Secondary outcomes

  1. change in total cholesterol concentration in serum

    Time frame: 4 weeks

    measured in an automatic spectrometer (mg/dL)

  2. change in tryglicerides concentration in serum

    Time frame: 4 weeks

    measured in an automatic spectrometer (mg/dL)

  3. change in HDL concentration in serum

    Time frame: 4 weeks

    measured in an automatic spectrometer (mg/dL)

  4. change in LDL concentration in serum

    Time frame: 4 weeks

    measured in an automatic spectrometer (mg/dL)

  5. change in protein-c reactive concentration in serum

    Time frame: 4 weeks

    measured in an automatic spectrometer (mg/dL)

  6. change in Plasma MDA concentrations (malondialdehyde)

    Time frame: 4 weeks

    measured in an automatic spectrometer (mg/dL)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Aix Marseille Université
  • Newcastle University
  • University of Aberdeen

Registry information

Official study title

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

Acronym: SUBRANUT

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Apr 12, 2017
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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