Chronic Kidney DiseasesNCT06394544
Effects of Brazil Nut Supplementation in Patients With Chronic Kidney Disease Undergoing Conservative Treatment
A study testing Brazil Nut in people with Chronic Kidney Diseases and Chronic Kidney Disease stage3, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease Stage 3A
- What is being tested?
- Brazil Nut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Mar 2025to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Inflammation
- Being tested
- Brazil Nut
- Keywords
- Chronic Kidney Diseases, Conservative treatment, Inflammation, Oxidative stress, Intestinal microbiota, Brazil Nut
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brazil NutDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Brazil nut | Experimental | 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. Receives: Dietary Supplement: Brazil Nut |
| Washout | No intervention | Time T2 will be a washout period , so that residual effects between stages T1 and T3 are avoided. |
| Crossover | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in antioxidants and anti-inflammatory biomarkers
Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1).
Measured: 8 weeks
Secondary outcomes (2)
Change in inflammatory biomarkers
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).
Measured: 8 weeks
Change in microbiota composition
DNA extraction from fecal samples will be carried out using the kit QIAamp DNA Stool Mini Kit.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start30 Mar 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A longitudinal, prospective clinical trial will be carried out with patients with CKD undergoing conservative treatment. Volunteers will be randomized into groups G1 and G2, and in the first stage, G1 will be in the intervention group and G2 in the control group. In the second stage, everyone will undergo washout and, in the third stage, a crossover between groups will be carried out, passing G2 to intervention and G1 to control.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renata Rodrigues, MS, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394544
- Sponsor's protocol ID
- DeniseMafraCPA
- Status last verified
- May 2026
- First submitted
- 27 Apr 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brazil Nut Supplementation on Inflammation, Oxidative Stress and Microbiota in Patients With Chronic Kidney Disease Undergoing Conservative Treatment
- ClinicalTrials.gov ID
- NCT06394544
- Acronym / sponsor ID
- DeniseMafraCPA
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Inflammation
- Keywords
- Chronic Kidney Diseases, Conservative treatment, Inflammation, Oxidative stress, Intestinal microbiota, Brazil Nut
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A longitudinal, prospective clinical trial will be carried out with patients with CKD undergoing conservative treatment. Volunteers will be randomized into groups G1 and G2, and in the first stage, G1 will be in the intervention group and G2 in the control group. In the second stage, everyone will undergo washout and, in the third stage, a crossover between groups will be carried out, passing G2 to intervention and G1 to control.
| Arm | Type | Receives |
|---|---|---|
| Brazil nut | Experimental | Dietary Supplement: Brazil NutEach 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. |
| Washout | No intervention | –Time T2 will be a washout period , so that residual effects between stages T1 and T3 are avoided. |
| Crossover | No intervention | –the crossover between the groups will allow the same participant to be exposed, at different times, to the intervention stage and the control stage. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brazil NutThe 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. | Dietary supplement | Brazil nut |
Primary outcome
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).
2 secondary outcomes
Change in inflammatory biomarkers
Time frame: 8 weeks
Change in microbiota composition
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Rodrigues, MS principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brazil Nut in people with Chronic Kidney Diseases and Chronic Kidney Disease stage3, run by Universidade Federal Fluminense at 1 site in Brazil.
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: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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 antioxidants and anti-inflammatory biomarkers (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026.