Effects of Sulforaphane for Patients With Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Salutary Effects of Sulforaphane for Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04608903
• Other study ID #: DeniseMafra11
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Universidade Federal Fluminense
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• L-sulforaphane 1%
Administration of 4g L-sulforaphane per day, for 2 months
• Placebo Group
Administration of 4g corn starch colored with chlorophyll, per day, for 2 months

Locations

Country	Name	City	State
Brazil	Denise Mafra	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Inflammatory biomarker	Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)	6 months
Secondary	Uremic toxins	Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels	6 months