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

Universidade Federal Fluminense

Status: Begins enrollment in 3 months

Conditions: Chronic Kidney Diseases; Inflammation; Chronic Kidney Disease stage3; Chronic Kidney Disease stage4; Intestinal Microbiota; Chronic Kidney Disease Stage 3B; Inflammatory Response; Chronic Kidney Disease Stage 3A; Oxidative Stress

Treatments: Dietary Supplement: Brazil Nut

Study type: Interventional

Funder types: Other

Identifiers

NCT06394544

DeniseMafraCPA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Brazil nut

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Brazil Nut

Washout

No Intervention group

Description:

Time T2 will be a washout period , so that residual effects between stages T1 and T3 are avoided.

Crossover

No Intervention group

Description:

the crossover between the groups will allow the same participant to be exposed, at different times, to the intervention stage and the control stage.