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
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 3B
• Chronic Kidney Disease stage3
• Chronic Kidney Disease stage4
• Chronic Kidney Diseases
• Inflammation
• Inflammatory Response
• Intestinal Microbiota
• Kidney Diseases
• Oxidative Stress
• Renal Insufficiency, Chronic

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