Chronic Kidney Disease
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTL-sulforaphane 1%
Administration of 4g L-sulforaphane per day, for 2 months
DIETARY_SUPPLEMENTPlacebo Group
Administration of 4g corn starch colored with chlorophyll, per day, for 2 months
Sponsors
Universidade Federal Fluminense
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Sulforaphane group or Placebo group. Thus, 52 participants with CKD under conservative treatment will be recruited at the Renal Nutrition Clinic of UFF and 70 patients under regular HD treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Criteria Inclusion Criteria: * Aged 18 to 75 years * Clinical diagnosis of Chronic Kidney Disease * Conservative treatment group: CKD stages 3 and 5 receiving nutritional treatment for at least 6 months * Hemodialysis group: Hemodialysis patients for more than 6 months
Exclusion criteria
* Patients pregnant * Smokers * Using antibiotics in the last 3 months * Autoimmune diseases * Clinical diagnosis of infectious diseases * Clinical diagnosis of Cancer * Clinical diagnosis of AIDS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory biomarker | 6 months | Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB) |
| Antioxidant and anti-inflammatory biomarker | 6 months | Get blood samples to evaluate the supplementation effects in antioxidant and anti-inflammatory biomarker- nuclear receptor factor 2 (Nrf2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uremic toxins | 6 months | Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels |
Countries
Brazil
Outcome results
None listed