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Active Not RecruitingNCT04608903

Effects of Sulforaphane for Patients With Chronic Kidney Disease

Salutary Effects of Sulforaphane for Patients With Chronic Kidney Disease

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
25 (estimated)
Sponsor
Universidade Federal Fluminense · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Patients with Chronic Kidney Disease (CKD) have many complications associated with inflammation, oxidative stress and intestinal dysbiosis, which are closely related to the progression of kidney failure and cardiovascular disease. Sulforaphane, an isothiocyanate found in cruciferous vegetables (Family: Brassicaceae) is recognized as one of the most important activators of erythroid nuclear factor 2 related to factor 2 (Nrf2). However, clinical evidence to assess the effects of sulforaphane in patients with CKD is scarce, and there are no studies that have investigated its effects on the expression of genes and markers related to inflammation in these patients. Thus, the present project proposes a longitudinal study of the clinical trial type that aims to evaluate the effects of sulforaphane on transcription factors and inflammatory markers in patients with CKD.

Detailed description

This is a longitudinal, randomized, crossover study with patients with CKD on hemodialysis and in non-dialysis patients. Both groups will receive 4g of sulforaphane per day for 2 months and the placebo group will receive 4g of corn starch colored with chlorophyll for 2 months. Peripheral blood mononuclear cells (PBMC) are being isolated for expression of Nrf2, NF-kB, and NADPH quinone oxidoreductase 1 (NQO1), HO-1, VCAM-1, E-selectin, NLRP3, IL-1B, IL 18, PGC1-α, sentrins, NRF2, NRF-1 e TFAM mRNA expression by a quantitative real-time polymerase chain reaction. Antioxidant enzymes activity (catalase-CAT and glutathione peroxidase-GPx), high-sensitivity C-reactive protein (hs-CRP) will be assessed using an enzyme-linked immunosorbent assay (ELISA).The serum concentration of other cytokines and growth factors will be detected by means of a multiparametric immunoassay based on magnetic microspheres marked with XMap (Luminex Corp, USA) before and after supplementation.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTL-sulforaphane 1%Administration of 4g L-sulforaphane per day, for 2 months
DIETARY_SUPPLEMENTPlacebo GroupAdministration of 4g corn starch colored with chlorophyll, per day, for 2 months

Timeline

Start date
2021-12-01
Primary completion
2023-12-31
Completion
2026-12-31
First posted
2020-10-29
Last updated
2025-04-03

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT04608903. Inclusion in this directory is not an endorsement.