Effects of Genetic Variations in the Response to Brazil Nut Supplementation (SUBRANUT)

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

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.

Study Overview

• Status: Completed
• Conditions: Dietary Supplements
• Intervention / Treatment: Dietary supplement: Brazil nut

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brazil Nut supplementation; Consumption of one Brazil nut a day for 2 months followed by 2 months without intervention	Dietary supplement: Brazil nut; one nut a day for 2 months, no intervention for 2 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Newcastle University; Aix Marseille Université; University of Aberdeen
• Investigators: Principal Investigator: Silvia MF Cozzolino, PhD, University of São Paulo

Publications and helpful links

General Publications

• 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):81. doi: 10.3390/nu8050081.
• 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. 2018 Aug;57(5):1873-1882. doi: 10.1007/s00394-017-1470-7. Epub 2017 May 13.
• 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):739. doi: 10.3390/nu9070739.
• 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.BRA.NUT study). Clin Nutr. 2019 Apr;38(2):539-548. doi: 10.1016/j.clnu.2018.03.011. Epub 2018 Mar 23.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): August 15, 2014
• Study Completion (Actual): April 19, 2016

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: micronutrients; nutrigenetics; nutrigenomics; nuts
• Other Study ID Numbers: USPBR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No