Clinical trial NCT06394544: Effects of Brazil Nut Supplementation in Patients With Chronic Kidney Disease Undergoing Conservative Treatment
Official title: Effects of Brazil Nut Supplementation on Inflammation, Oxidative Stress and Microbiota in Patients With Chronic Kidney Disease Undergoing Conservative Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Keywords: Chronic Kidney Diseases
Conservative treatment
Inflammation
Oxidative stress
Intestinal microbiota
Brazil Nut
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in antioxidants and anti-inflammatory biomarkers
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in inflammatory biomarkers
timeFrame: 8 weeks
measure: Change in microbiota composition
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Denise Mafra
state: RJ
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Renata Rodrigues, MS
role: PRINCIPAL_INVESTIGATOR
References: