An interventional study of Brazil Nut in Chronic Kidney Diseases, Chronic Kidney Disease stage3 and Chronic Kidney Disease Stage 3A, sponsored by Universidade Federal Fluminense. Active, not recruiting at 1 site in Brazil. Open to participants aged 20 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Universidade Federal Fluminense · Not applicable, Interventional, and Health services research
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.
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.
3,144 studies on the registry are indexed under Renal Insufficiency, Chronic; 704 are open to participants now.
This study's planned enrollment of 50 is below the median of 74 across 2,176 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Universidade Federal Fluminense is the lead sponsor of 72 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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
Time T2 will be a washout period , so that residual effects between stages T1 and T3 are avoided.
the crossover between the groups will allow the same participant to be exposed, at different times, to the intervention stage and the control stage.
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.
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).
Time frame: 8 weeks
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).
Time frame: 8 weeks
Change in microbiota composition
DNA extraction from fecal samples will be carried out using the kit QIAamp DNA Stool Mini Kit.
Time frame: 8 weeks
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Universidade Federal Fluminense