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Effects of Sulforaphane for Patients With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04608903
Recruitment Status : Active, not recruiting
First Posted : October 29, 2020
Last Update Posted : February 26, 2024
Sponsor:
Information provided by (Responsible Party):
Universidade Federal Fluminense

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: L-sulforaphane 1% Dietary Supplement: Placebo Group Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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
Official Title: Salutary Effects of Sulforaphane for Patients With Chronic Kidney Disease
Actual Study Start Date : December 1, 2021
Actual Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
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.
 Dietary Supplement: L-sulforaphane 1%
Administration of 4g L-sulforaphane per day, for 2 months
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.
 Dietary Supplement: Placebo Group
Administration of 4g corn starch colored with chlorophyll, per day, for 2 months


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. Inflammatory biomarker [ Time Frame: 6 months ]
    Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)


Secondary Outcome Measures :
  1. Uremic toxins [ Time Frame: 6 months ]
    Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608903


Locations
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Brazil
Denise Mafra
Rio de Janeiro, Brazil, 22260050
Sponsors and Collaborators
Universidade Federal Fluminense
More Information
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Publications:

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Responsible Party: Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT04608903    
Other Study ID Numbers: DeniseMafra11
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: February 26, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
 Chronic Disease
Disease Attributes
Pathologic Processes
Sulforaphane
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents