Salutary Effects of Sulforaphane for Patients With Chronic Kidney Disease
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Antioxidant and anti-inflammatory biomarker
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Using antibiotics in the last 3 months
- •Autoimmune diseases
- •Clinical diagnosis of infectious diseases
- •Clinical diagnosis of Cancer
- •Clinical diagnosis of AIDS
Outcomes
Primary Outcomes
Antioxidant and anti-inflammatory biomarker
Time Frame: 6 months
Get blood samples to evaluate the supplementation effects in antioxidant and anti-inflammatory biomarker- nuclear receptor factor 2 (Nrf2)
Inflammatory biomarker
Time Frame: 6 months
Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)
Secondary Outcomes
- Uremic toxins(6 months)