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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulforaphane Group | Experimental | 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. |
|
| Placebo Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-sulforaphane 1% | Dietary Supplement | Administration of 4g L-sulforaphane per day, for 2 months |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Uremic toxins | Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels | 6 months |
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Criteria
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denise Mafra | Rio de Janeiro | 22260050 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33338213 | Background | Cardozo LFMF, Alvarenga LA, Ribeiro M, Dai L, Shiels PG, Stenvinkel P, Lindholm B, Mafra D. Cruciferous vegetables: rationale for exploring potential salutary effects of sulforaphane-rich foods in patients with chronic kidney disease. Nutr Rev. 2021 Oct 11;79(11):1204-1224. doi: 10.1093/nutrit/nuaa129. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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
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| Placebo Group | Dietary Supplement | Administration of 4g corn starch colored with chlorophyll, per day, for 2 months |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |