Effects of Brazil Nut Supplementation in Patients With Chronic Kidney Disease Undergoing Conservative Treatment

May 14, 2026 updated by: Universidade Federal Fluminense

Effects of Brazil Nut Supplementation on Inflammation, Oxidative Stress and Microbiota in Patients With Chronic Kidney Disease Undergoing Conservative Treatment

The aim of this study is to evaluate the effects of Brazil nut supplementation on inflammation, oxidative stress and intestinal microbiota in patients with chronic kidney disease undergoing conservative treatment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Complications such as inflammation and oxidative stress are common in chronic kidney disease (CKD) and directly influence the rate of disease progression. Patients with CKD also have intestinal dysbiosis, which aggravates the inflammatory process and oxidative stress, forming a vicious circle between inflammation, oxidative stress and intestinal dysbiosis. Nutritional strategies try to alleviate this circle and Brazil nuts, rich in bioactive compounds, have already been proven effective in mitigating inflammation and oxidative stress in CKD patients on dialysis. However, to date, the effectiveness of Brazil nuts in patients with CKD in stages prior to dialysis (conservative treatment) has not been tested. The bioactive compounds in Brazil nuts are expected to contribute positively to the redox balance, reduction of inflammation and intestinal eubiosis in patients with CKD undergoing conservative treatment.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 22260050
        • Denise Mafra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with more than three months of nutritional monitoring at the Renal Nutrition Outpatient Clinic of the Universidade Federal Fluminense (UFF), between stages G3a and G4, will be included, according to KDOQI 2020 guidelines, and authorized by the medical and nutritionist team.

Exclusion Criteria:

  • Current use or in the last three months of antibiotics, anti-inflammatories and/or antioxidant supplements. Patients who are allergic, intolerant, or regularly ingest Brazil nuts; pregnant/lactating women, smokers; undergoing cancer treatment, HIV-positive, or with any clinical condition that compromises the accuracy of the intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brazil nut

Each patient will receive 30 units of Brazil nuts per month, to consume one nut/day for two months. The time and daily amount of nuts were based on the European Food Safety recommendation Authority (EFSA). The adequate value for selenium intake was determined by EFSA aiming at the maximum serum concentration of Selenoprotein P and glutathione peroxidase activity, reached between four and 10 weeks, with 70 µg/day; we consider that a Brazil nut can contain up to 400 µg of Se.

The use of fresh nuts made it impossible to use a placebo with the same sensory characteristics. Then, in the control stage, volunteers will receive conventional conservative nutritional treatment, without nut supplementation.
Dietary supplement: Brazil Nut
The intervention, for each participant, is estimated to last a total period of six months , which will be divided into three two-month stages, with data collection after each stage. Volunteers will be monitored to control possible side effects, doubts and check compliance. In addition, the telephone number and an email will be made available for contact during business hours, for possible clarifications.
No Intervention: Washout
Time T2 will be a washout period , so that residual effects between stages T1 and T3 are avoided.
No Intervention: Crossover
the crossover between the groups will allow the same participant to be exposed, at different times, to the intervention stage and the control stage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in antioxidants and anti-inflammatory biomarkers
Time Frame: 8 weeks
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inflammatory biomarkers
Time Frame: 8 weeks
Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha).
8 weeks
Change in microbiota composition
Time Frame: 8 weeks
DNA extraction from fecal samples will be carried out using the kit QIAamp DNA Stool Mini Kit.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal Fluminense

Investigators

  • Principal Investigator: Renata Rodrigues, MS, Universidade Federal do Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2025

Primary Completion (Actual)

October 30, 2025

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

April 27, 2024

First Submitted That Met QC Criteria

April 27, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DeniseMafraCPA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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