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AzTrials

Dietary SupplementsSUBRANUTNCT03111355

Effects of Genetic Variations in the Response to Brazil Nut Supplementation

A study testing Brazil nut in people with Dietary Supplements, run by University of Sao Paulo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Dietary Supplements
What is being tested?
Brazil nut
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
No sites listed yet
Study dates
1 Mar 2013to 19 Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: 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.

Read the 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 .

Being tested
Brazil nut
Keywords
nuts, micronutrients, nutrigenomics, nutrigenetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brazil nutDietary supplement

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

Study groups in NCT03111355
Study groupRoleWhat they receive
Brazil Nut supplementationExperimentalConsumption of one Brazil nut a day for 2 months followed by 2 months without intervention
Receives: Dietary Supplement: Brazil nut

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in Plasma Se concentrations

    measured by ICP-MS (ug/L)

    Measured: 4 weeks

  2. change in Plasma Glutathione Peroxidase 3 activity

    measured by kinetic assay in a spectrometer (U/L)

    Measured: 4 weeks

  3. change in Plasma Selenoprotein P concentrations

    measured by ELISA (mg/dL)

    Measured: 4 weeks

  4. change in Erythrocyte Se concentrations

    measured by ICP-MS (ug/L)

    Measured: 4 weeks

  5. change in Erythrocyte Glutathione Peroxidase 1 activity

    measured by kinetic assay in an automatic spectrometer (U/gHb)

    Measured: 4 weeks

Secondary outcomes (6)

  1. change in total cholesterol concentration in serum

    measured in an automatic spectrometer (mg/dL)

    Measured: 4 weeks

  2. change in tryglicerides concentration in serum

    measured in an automatic spectrometer (mg/dL)

    Measured: 4 weeks

  3. change in HDL concentration in serum

    measured in an automatic spectrometer (mg/dL)

    Measured: 4 weeks

  4. change in LDL concentration in serum

    measured in an automatic spectrometer (mg/dL)

    Measured: 4 weeks

  5. change in protein-c reactive concentration in serum

    measured in an automatic spectrometer (mg/dL)

    Measured: 4 weeks

  6. change in Plasma MDA concentrations (malondialdehyde)

    measured in an automatic spectrometer (mg/dL)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2017
  2. Study start1 Mar 2013
  3. Primary completion15 Aug 2014
  4. Study completion19 Apr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03111355
Sponsor's protocol ID
USPBR
Acronym
SUBRANUT
Status last verified
May 2018
First submitted
27 Mar 2017
Last updated
1 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 27164132

  • 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.

    PubMed 28501922

  • 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.

    PubMed 28696394

  • 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.

    PubMed 29609868

Questions about this trial

What is this clinical trial studying?

A study testing Brazil nut in people with Dietary Supplements, run by University of Sao Paulo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in Plasma Se concentrations (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03111355, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.

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