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NCT06394544 Clinical Trial

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

Inflammation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06394544
Other study ID # DeniseMafraCPA
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date March 2027

Study information
Verified date February 2024
Source Universidade Federal Fluminense
Contact Denise Mafra, Ph.D
Phone 5521985683003
Email dmafra30@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date March 2027
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 59 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Brazil Nut
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.

Locations
Country Name City State
Brazil Denise Mafra Rio de Janeiro RJ

Sponsors (1)
Lead Sponsor Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 8 weeks
Secondary 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). 8 weeks
Secondary Change in microbiota composition DNA extraction from fecal samples will be carried out using the kit QIAamp DNA Stool Mini Kit. 8 weeks
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