Effects of Sulforaphane for Patients With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
L-sulforaphane 1%
Placebo Group
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Kidney Disease
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
Sites / Locations
- Denise MafraRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sulforaphane Group
Placebo Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Antioxidant and anti-inflammatory biomarker
Get blood samples to evaluate the supplementation effects in antioxidant and anti-inflammatory biomarker- nuclear receptor factor 2 (Nrf2)
Inflammatory biomarker
Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)
Secondary Outcome Measures
Uremic toxins
Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels
Full Information
NCT ID
NCT04608903
First Posted
October 25, 2020
Last Updated
January 4, 2022
Sponsor
Universidade Federal Fluminense
1. Study Identification
Unique Protocol Identification Number
NCT04608903
Brief Title
Effects of Sulforaphane for Patients With Chronic Kidney Disease
Official Title
Salutary Effects of Sulforaphane for Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade Federal Fluminense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sulforaphane Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
L-sulforaphane 1%
Intervention Description
Administration of 4g L-Sulforaphane per day, for 2 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Group
Intervention Description
Administration of 4g corn starch colored with chlorophyll, per day, for 2 months
Primary Outcome Measure Information:
Title
Antioxidant and anti-inflammatory biomarker
Description
Get blood samples to evaluate the supplementation effects in antioxidant and anti-inflammatory biomarker- nuclear receptor factor 2 (Nrf2)
Time Frame
6 months
Title
Inflammatory biomarker
Description
Get blood samples to evaluate the supplementation effects in inflammatory biomarker- factor nuclear kappa B (NFkB)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Uremic toxins
Description
Get blood samples to evaluate the supplementation effects on uremic toxins plasma levels
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Mafra, Phd
Phone
+55 21 985683003
Email
dmafra30@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Mafra
Phone
+5521985683003
Email
dmafra30@gmail.com
Facility Information:
Facility Name
Denise Mafra
City
Rio de Janeiro
ZIP/Postal Code
22260050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Mafra, phd
Phone
21985683003
Email
dmafra30@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33338213
Citation
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.
Results Reference
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Effects of Sulforaphane for Patients With Chronic Kidney Disease
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