Effects of Sulforaphane for Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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, Sestrina, 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.

Official Title
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Salutary Effects of Sulforaphane for Patients With Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: L-sulforaphane 1%
* Dietary Supplement: Placebo Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sulforaphane Group<br>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%<br>* Administration of 4g L-Sulforaphane per day, for 2 months<br>Dietary Supplement: Placebo Group<br>* Administration of 4g corn starch colored with chlorophyll, per day, for 2 months<br>|
| Placebo Comparator: Placebo Group<br>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: L-sulforaphane 1%<br>* Administration of 4g L-Sulforaphane per day, for 2 months<br>Dietary Supplement: Placebo Group<br>* Administration of 4g corn starch colored with chlorophyll, per day, for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antioxidant and anti-inflammatory biomarker | Get blood samples to evaluate the supplementation effects in antioxidant and anti-inflammatory biomarker- nuclear receptor factor 2 (Nrf2) | 6 months | 
| Inflammatory biomarker | Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uremic toxins | Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels | 6 months |