NCT03111355

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2014

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

March 27, 2017

Last Update Submit

May 30, 2018

Conditions

Dietary Supplements

Keywords

nutsmicronutrientsnutrigenomicsnutrigenetics

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • change in total cholesterol concentration in serum

    4 weeks

  • change in tryglicerides concentration in serum

    4 weeks

  • change in HDL concentration in serum

    4 weeks

  • change in LDL concentration in serum

    4 weeks

  • change in protein-c reactive concentration in serum

    4 weeks

  • +1 more secondary outcomes

Study Arms (1)

Brazil Nut supplementation

EXPERIMENTAL

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

Dietary Supplement: Brazil nut

Interventions

Brazil nutDIETARY_SUPPLEMENT

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

Brazil Nut supplementation

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 20 and 60 years; not taking vitamin and minerals supplements, not taking antiinflammatory, not having chronic diseases

You may not qualify if:

  • athletes, excessive alcohol consumption, being obese, having cancer, cardiovascular disease, diabetes and hypo or hyperthyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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):81. doi: 10.3390/nu8050081.

    PMID: 27164132RESULT

  • 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.

    PMID: 28501922RESULT

  • 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.

    PMID: 28696394RESULT

  • 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.

    PMID: 29609868RESULT

MeSH Terms

Interventions

2S albumin, brazil nut

Study Officials

  • Silvia MF Cozzolino, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2017

First Posted

April 12, 2017

Study Start

March 1, 2013

Primary Completion

August 15, 2014

Study Completion

April 19, 2016

Last Updated

June 1, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share