Effects of Genetic Variations in the Response to Brazil Nut Supplementation

Dietary Supplements Clinical Trial

— SUBRANUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111355
• Other study ID #: USPBR
• Status: Completed
• Phase: N/A
• Start date: March 1, 2013
• Est. completion date: April 19, 2016

Study information

• Verified date: May 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: April 19, 2016
• Est. primary completion date: August 15, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Supplements

Intervention

Dietary Supplement:
• Brazil nut
one nut a day for 2 months, no intervention for 2 months

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo	Aix Marseille Université, Newcastle University, University of Aberdeen

References & Publications (4)

Donadio JL, Guerra-Shinohara EM, Rogero MM, Cozzolino SM. Influence of Gender and SNPs in GPX1 Gene on Biomarkers of Selenium Status in Healthy Brazilians. Nutrients. 2016 May 5;8(5). pii: E81. doi: 10.3390/nu8050081. — View Citation

Donadio JLS, Rogero MM, Cockell S, Hesketh J, Cozzolino SMF. Influence of Genetic Variations in Selenoprotein Genes on the Pattern of Gene Expression after Supplementation with Brazil Nuts. Nutrients. 2017 Jul 11;9(7). pii: E739. doi: 10.3390/nu9070739. — View Citation

Donadio JLS, Rogero MM, Guerra-Shinohara EM, Barbosa F Jr., Desmarchelier C, Borel P, Sneddon AA, Hesketh JE, Cozzolino SMF. Genetic variants in selenoprotein genes modulate biomarkers of selenium status in response to Brazil nut supplementation (the SU.B — View Citation

Donadio JLS, Rogero MM, Guerra-Shinohara EM, Desmarchelier C, Borel P, Cozzolino SMF. SEPP1 polymorphisms modulate serum glucose and lipid response to Brazil nut supplementation. Eur J Nutr. 2017 May 13. doi: 10.1007/s00394-017-1470-7. [Epub ahead of prin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Plasma Se concentrations	measured by ICP-MS (ug/L)	4 weeks
Primary	change in Plasma Glutathione Peroxidase 3 activity	measured by kinetic assay in a spectrometer (U/L)	4 weeks
Primary	change in Plasma Selenoprotein P concentrations	measured by ELISA (mg/dL)	4 weeks
Primary	change in Erythrocyte Se concentrations	measured by ICP-MS (ug/L)	4 weeks
Primary	change in Erythrocyte Glutathione Peroxidase 1 activity	measured by kinetic assay in an automatic spectrometer (U/gHb)	4 weeks
Secondary	change in total cholesterol concentration in serum	measured in an automatic spectrometer (mg/dL)	4 weeks
Secondary	change in tryglicerides concentration in serum	measured in an automatic spectrometer (mg/dL)	4 weeks
Secondary	change in HDL concentration in serum	measured in an automatic spectrometer (mg/dL)	4 weeks
Secondary	change in LDL concentration in serum	measured in an automatic spectrometer (mg/dL)	4 weeks
Secondary	change in protein-c reactive concentration in serum	measured in an automatic spectrometer (mg/dL)	4 weeks
Secondary	change in Plasma MDA concentrations (malondialdehyde)	measured in an automatic spectrometer (mg/dL)	4 weeks