Trials / Active Not Recruiting
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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | L-sulforaphane 1% | Administration of 4g L-sulforaphane per day, for 2 months |
| DIETARY_SUPPLEMENT | Placebo Group | Administration 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.