Clinical trial NCT03111355: Effects of Genetic Variations in the Response to Brazil Nut Supplementation
Official title: Genetic Variants in Selenoprotein Genes and Gender Influence Biomarkers of Se Status in Response to Brazil Nut Supplementation in Healthy Brazilians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplements
Keywords: nuts
micronutrients
nutrigenomics
nutrigenetics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Newcastle University
name: University of Aberdeen
name: Aix Marseille Université
First posted: 2017-04-12
Enrollment: 129
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 .

Eligibility criteria: 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

Primary outcomes:
measure: change in Plasma Se concentrations
timeFrame: 4 weeks
measure: change in Plasma Glutathione Peroxidase 3 activity
timeFrame: 4 weeks
measure: change in Plasma Selenoprotein P concentrations
timeFrame: 4 weeks
measure: change in Erythrocyte Se concentrations
timeFrame: 4 weeks
measure: change in Erythrocyte Glutathione Peroxidase 1 activity
timeFrame: 4 weeks
Secondary outcomes:
measure: change in total cholesterol concentration in serum
timeFrame: 4 weeks
measure: change in tryglicerides concentration in serum
timeFrame: 4 weeks
measure: change in HDL concentration in serum
timeFrame: 4 weeks
measure: change in LDL concentration in serum
timeFrame: 4 weeks
measure: change in protein-c reactive concentration in serum
timeFrame: 4 weeks
measure: change in Plasma MDA concentrations (malondialdehyde)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Silvia MF Cozzolino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. 2018 Aug;57(5):1873-1882. doi: 10.1007/s00394-017-1470-7. Epub 2017 May 13.
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):739. doi: 10.3390/nu9070739.
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.BRA.NUT study). Clin Nutr. 2019 Apr;38(2):539-548. doi: 10.1016/j.clnu.2018.03.011. Epub 2018 Mar 23.