Effects of Sulforaphane for Patients With Chronic Kidney Disease

• ClinicalTrials.gov Identifier: NCT04608903
• Recruitment Status: Active, not recruiting
• First Posted: October 29, 2020
• Last Update Posted: February 26, 2024
• Sponsor: Universidade Federal Fluminense
• Information provided by (Responsible Party): Universidade Federal Fluminense

Tracking Information

• First Submitted Date: October 25, 2020
• First Posted Date: October 29, 2020
• Last Update Posted Date: February 26, 2024
• Actual Study Start Date: December 1, 2021
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 3, 2020)

• 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)

Original Primary Outcome Measures (submitted: October 25, 2020)

• Antioxidants and anti-inflammatory biomarkers [ Time Frame: 6 months ]
  Get blood samples to evaluate the supplementation effects in antioxidants biomarkers- nuclear receptor factor 2 (Nrf2), glutathioneperoxidase (GPx), heme oxygenase-1 (HO-1)
• Inflammatory biomarkers [ Time Frame: 6 months ]
  Get blood samples to evaluate the supplementation effects in inflammatory biomarkers- factor nuclear kappa B (NFkB), interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-alpha)

Current Secondary Outcome Measures (submitted: October 25, 2020)

Uremic toxins [ Time Frame: 6 months ]

Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Sulforaphane for Patients With Chronic Kidney Disease
• Official Title: Salutary Effects of Sulforaphane for Patients With Chronic Kidney Disease
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
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

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research

• Condition: Chronic Kidney Disease

Intervention

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

Study Arms

• Experimental: Sulforaphane Group
  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.
  Intervention: Dietary Supplement: L-sulforaphane 1%
• Placebo Comparator: Placebo Group
  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.
  Intervention: Dietary Supplement: Placebo Group

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: February 23, 2024): 25
• Original Estimated Enrollment (submitted: October 25, 2020): 122
• Estimated Study Completion Date: December 31, 2024
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT04608903
• Other Study ID Numbers: DeniseMafra11
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Universidade Federal Fluminense
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidade Federal Fluminense
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universidade Federal Fluminense
• Verification Date: February 2024