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

NCT06394544 | Not Yet Recruiting

• 1 other identifier: DeniseMafraCPA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in inflammatory biomarkers

  8 weeks

• Change in microbiota composition

  8 weeks

Study Arms (3)

Brazil nut

EXPERIMENTAL

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

Washout

NO INTERVENTION

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

Crossover

NO INTERVENTION

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

Interventions

Brazil Nut DIETARY_SUPPLEMENT

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.

Brazil nut

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Denise Mafra

Rio de Janeiro, Rio de Janeiro, 22260050, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Interventions

2S albumin, brazil nut

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Renata Rodrigues, MS

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Mafra, Ph.D

CONTACT

5521985683003; dmafra30@gmail.com

Renata Rodrigues, MS

CONTACT

5591988110588; nutri.renatacris@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: August 30, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

BR (1)