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

University of Sao Paulo

Status: Completed

Conditions: Dietary Supplements

Treatments: Dietary Supplement: Brazil nut

Study type: Interventional

Funder types: Other

Identifiers

NCT03111355

USPBR

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 129 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

Brazil Nut supplementation

Experimental group

Description:

Consumption of one Brazil nut a day for 2 months followed by 2 months without intervention

Treatment:

Dietary Supplement: Brazil nut