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

NCT06394544 — Not applicable, Active not recruiting, 50 participants, Universidade Federal Fluminense

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

Registry	NCT06394544
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, health services research
Enrollment	50 (Estimated)
Sponsor	Universidade Federal Fluminense (Other)
Conditions	Chronic Kidney Diseases, Chronic Kidney Disease stage3, Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Inflammation, Inflammatory Response, Oxidative Stress, Intestinal Microbiota
Interventions	Brazil Nut (Dietary supplement)
Dates	start 2025-03-30, primary completion 2025-10-30, completion 2027-10-30 (estimated), first posted 2024-05-01, last updated 2026-05-18
Locations	1 site in Brazil

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Brazil nut	Experimental	Dietary Supplement: 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.
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.

Brazil Nut (Dietary 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.

+Outcome measures

Primary outcomes

Change in antioxidants and anti-inflammatory biomarkers [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).

Secondary outcomes

Change in inflammatory biomarkers [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).
Change in microbiota composition [8 weeks]: DNA extraction from fecal samples will be carried out using the kit QIAamp DNA Stool Mini Kit.

+Eligibility

Sex: All, ages: 20 Years to 59 Years

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.

+Locations (1)

Facility	City	Country	Status
Denise Mafra	Rio de Janeiro, Rio de Janeiro	Brazil

+Investigators

Renata Rodrigues, MS, Principal investigator, Universidade Federal do Rio de Janeiro

My Notes

Public

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