An interventional study of L-sulforaphane 1% and Placebo Group in Chronic Kidney Disease, sponsored by Universidade Federal Fluminense. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Universidade Federal Fluminense · Not applicable, Interventional, and Health services research
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 25 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Universidade Federal Fluminense is the lead sponsor of 72 studies on the registry; 13 are open to participants now.
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Criteria
Inclusion Criteria:
Exclusion Criteria:
Administration of 4g L-sulforaphane per day, for 2 months and after the washout period (2 months) the groups will be crossed and will receive the same amount of placebo as the other group for 2 months.
Dietary Supplement: L-sulforaphane 1%
Administration of 4g of corn starch colored with chlorophyll, per day, for 2 months and then after the washout period (2 months) the groups will be crossed and will receive the same amount of sulfarophane as the treatment group.
Dietary Supplement: Placebo Group
Administration of 4g L-sulforaphane per day, for 2 months
Administration of 4g corn starch colored with chlorophyll, per day, for 2 months
Antioxidant and anti-inflammatory biomarker
Get blood samples to evaluate the supplementation effects in antioxidant and anti-inflammatory biomarker- nuclear receptor factor 2 (Nrf2)
Time frame: 6 months
Inflammatory biomarker
Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)
Time frame: 6 months
Uremic toxins
Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels
Time frame: 6 months
Plan to share: No
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Universidade Federal Fluminense