Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
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| ClinicalTrials.gov Identifier: NCT01315665 |
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Recruitment Status :
Completed
First Posted : March 15, 2011
Results First Posted : February 15, 2017
Last Update Posted : February 15, 2019
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Sponsor:
University Hospitals Cleveland Medical Center
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
James F. Chmiel, University Hospitals Cleveland Medical Center
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Brief Summary:
The purpose of this study to investigate the effect of sulforaphane from macerated broccoli sprouts in humans and to evaluate less invasive methods of assessing potential anti-inflammatory drugs in CF.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cystic Fibrosis | Dietary Supplement: Broccoli sprouts | Not Applicable |
The hypothesis to be tested is that sulforaphane consumed from macerated broccoli sprouts will activate Nrf2, reduce oxidative metabolites and reduce neutrophils in the oral mucosa after 5 days of therapy in healthy volunteers and CF subjects.
The study requires 6 brief outpatient visits over 8 days. Study procedures include medical history, height, weight, vital signs, blood and urine collection, nasal curettage, saline mouthwash, and ingestion of broccoli sprouts (100 gm of 3 to 5 day old raw broccoli sprouts once daily for 5 consecutive days).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 15 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Evaluation of the Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation, Measures of Oxidative Stress, and Neutrophil Migration to Mucosal Surfaces in Healthy and CF Subjects |
| Study Start Date : | April 2011 |
| Actual Primary Completion Date : | February 2013 |
| Actual Study Completion Date : | February 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Healthy volunteers
100 grams of raw broccoli sprouts once daily for 5 consecutive days
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Dietary Supplement: Broccoli sprouts
Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
Other Name: sulforaphane |
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Experimental: Subjects with cystic fibrosis
100 grams of raw broccoli sprouts once daily for 5 consecutive days
|
Dietary Supplement: Broccoli sprouts
Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
Other Name: sulforaphane |
Primary Outcome Measures :
- Nrf2 Activation in Nasal Epithelial Cells [ Time Frame: Baseline and of end of 5 day treatment period ]Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)
Secondary Outcome Measures :
- Measures of Lipid Peroxidation in Nasal Epithelial Cells [ Time Frame: End of 5 day treatment period ]Products of lipid peroxidation will be determined by western blot analysis on nasal epithelial cells obtained by curettage after 5 days of study treatment (consuming broccoli sprouts)
- Measures of Glutathione From Blood Lymphocytes [ Time Frame: Baseline and end of 5 day treatment period ]Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).
- Measures of Oxidative Stress in Urine [ Time Frame: Baseline and end of 5 day treatment period ]Change in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).
- Measure of Neutrophil Migration Into the Gingival Crevices [ Time Frame: Baseline and end of 5 day treatment period ]Change in gingival neutrophils measured after 5 days of study treatment (consuming broccoli sprouts). Patients will perform mouthwashes with normal saline. Neutrophil counts will be performed on fresh samples. Acridine orange will be added to the saline rinses and neutrophils will be counted under the microscope.
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| Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy volunteers and patients with cystic fibrosis ≥ 18 < 50 years of age
- Healthy volunteers must be in general good health as determined by a medical history
- CF subjects must have a documented diagnosis of CF (positive sweat chloride ≥ 60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF) phenotype
- CF subjects must have a baseline FEV1 percent predicted > 50% (in the last year, obtained from medical record)
- CF subjects must be clinically stable: free of any acute illness for > 14 days CF subjects must not have been prescribed any new systemic antibiotics for the 14 days prior to enrollment
- Ability to provide written informed consent
- Ability to adhere to the protocol
Exclusion Criteria:
- Use of NSAIDS (e.g., ibuprofen) or corticosteroids including inhaled steroids for the 4 weeks prior to enrollment
- Active gingival disease (active tooth or gum disease)
- History of nephrolithiasis or cholelithiasis
- Allergy to broccoli
- Any chronic condition that compromises the participant as determined by medical history
- Pregnancy
- Inability to tolerate the study procedures
- CF subjects: Infected with B. cepacia
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): NCT01315665
Locations
| United States, Ohio | |
| Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Cystic Fibrosis Foundation
Investigators
| Principal Investigator: | James F. Chmiel, MD, MPH | Rainbow Babies and Children's Hospital |
Publications:
| Responsible Party: | James F. Chmiel, Associate Professor of Pediatrics, University Hospitals Cleveland Medical Center |
| ClinicalTrials.gov Identifier: | NCT01315665 |
| Other Study ID Numbers: |
UHCMC-CFRC-2011-01 |
| First Posted: | March 15, 2011 Key Record Dates |
| Results First Posted: | February 15, 2017 |
| Last Update Posted: | February 15, 2019 |
| Last Verified: | January 2019 |
Keywords provided by James F. Chmiel, University Hospitals Cleveland Medical Center:
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broccoli sprouts sulforaphane triterpenoid Nrf2 activation |
cystic fibrosis healthy volunteers anti-inflammatory |
Additional relevant MeSH terms:
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Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases |
Genetic Diseases, Inborn Infant, Newborn, Diseases Sulforaphane Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs Antineoplastic Agents |