Cystic FibrosisNCT01315665
Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
A study testing Broccoli sprouts in people with Cystic Fibrosis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Broccoli sprouts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
About this study
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
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.
Read the detailed description
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).
- Conditions
- Cystic Fibrosis
- Being tested
- Broccoli sprouts
- Keywords
- broccoli sprouts, sulforaphane, triterpenoid, Nrf2 activation, cystic fibrosis, healthy volunteers, anti-inflammatory
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli sproutsDietary supplement
Also called sulforaphane
Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | 100 grams of raw broccoli sprouts once daily for 5 consecutive days Receives: Dietary Supplement: Broccoli sprouts |
| Subjects with cystic fibrosis | Experimental | 100 grams of raw broccoli sprouts once daily for 5 consecutive days Receives: Dietary Supplement: Broccoli sprouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nrf2 Activation in Nasal Epithelial Cells
Number of subjects with activated Nrf-2 in the cytoplasm of nasal epithelial cells after 5 days of study treatment (consuming broccoli sprouts)
Measured: Baseline and of end of 5 day treatment period
Secondary outcomes (4)
Measures of Lipid Peroxidation in Nasal Epithelial Cells
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)
Measured: End of 5 day treatment period
Measures of Glutathione From Blood Lymphocytes
Change in lymphocyte glutathione measurements after 5 days of study treatment (consuming broccoli sprouts).
Measured: Baseline and end of 5 day treatment period
Measures of Oxidative Stress in Urine
Change in urine bromotyrosine (measured by mass spectrometry) will be measured after 5 days of study treatment (consuming broccoli sprouts).
Measured: Baseline and end of 5 day treatment period
Measure of Neutrophil Migration Into the Gingival Crevices
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.
Measured: Baseline and end of 5 day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, James F. Chmiel, University Hospitals Cleveland Medical Center
- Investigators
- James F. Chmiel, MD, MPH, Principal investigator, Rainbow Babies and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315665
- Sponsor's protocol ID
- UHCMC-CFRC-2011-01
- Status last verified
- Jan 2019
- First submitted
- 14 Mar 2011
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chmiel JF, Berger M, Konstan MW. The role of inflammation in the pathophysiology of CF lung disease. Clin Rev Allergy Immunol. 2002 Aug;23(1):5-27. doi: 10.1385/CRIAI:23:1:005.
PubMed 12162106Chen J, Kinter M, Shank S, Cotton C, Kelley TJ, Ziady AG. Dysfunction of Nrf-2 in CF epithelia leads to excess intracellular H2O2 and inflammatory cytokine production. PLoS One. 2008;3(10):e3367. doi: 10.1371/journal.pone.0003367. Epub 2008 Oct 10.
PubMed 18846238Nichols DP, Ziady AG, Shank SL, Eastman JF, Davis PB. The triterpenoid CDDO limits inflammation in preclinical models of cystic fibrosis lung disease. Am J Physiol Lung Cell Mol Physiol. 2009 Nov;297(5):L828-36. doi: 10.1152/ajplung.00171.2009. Epub 2009 Aug 21.
PubMed 19700644Verhaeghe C, Remouchamps C, Hennuy B, Vanderplasschen A, Chariot A, Tabruyn SP, Oury C, Bours V. Role of IKK and ERK pathways in intrinsic inflammation of cystic fibrosis airways. Biochem Pharmacol. 2007 Jun 15;73(12):1982-94. doi: 10.1016/j.bcp.2007.03.019. Epub 2007 Mar 24.
PubMed 17466952Li J, Johnson XD, Iazvovskaia S, Tan A, Lin A, Hershenson MB. Signaling intermediates required for NF-kappa B activation and IL-8 expression in CF bronchial epithelial cells. Am J Physiol Lung Cell Mol Physiol. 2003 Feb;284(2):L307-15. doi: 10.1152/ajplung.00086.2002. Epub 2002 Sep 27.
PubMed 12388360Escotte S, Tabary O, Dusser D, Majer-Teboul C, Puchelle E, Jacquot J. Fluticasone reduces IL-6 and IL-8 production of cystic fibrosis bronchial epithelial cells via IKK-beta kinase pathway. Eur Respir J. 2003 Apr;21(4):574-81. doi: 10.1183/09031936.03.00031803.
PubMed 12762338Lands LC, Stanojevic S. Oral non-steroidal anti-inflammatory drug therapy for cystic fibrosis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001505. doi: 10.1002/14651858.CD001505.pub2.
PubMed 17943753Flume PA, O'Sullivan BP, Robinson KA, Goss CH, Mogayzel PJ Jr, Willey-Courand DB, Bujan J, Finder J, Lester M, Quittell L, Rosenblatt R, Vender RL, Hazle L, Sabadosa K, Marshall B; Cystic Fibrosis Foundation, Pulmonary Therapies Committee. Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2007 Nov 15;176(10):957-69. doi: 10.1164/rccm.200705-664OC. Epub 2007 Aug 29.
PubMed 17761616Oermann CM, Sockrider MM, Konstan MW. The use of anti-inflammatory medications in cystic fibrosis: trends and physician attitudes. Chest. 1999 Apr;115(4):1053-8. doi: 10.1378/chest.115.4.1053.
PubMed 10208207Konstan MW. Ibuprofen therapy for cystic fibrosis lung disease: revisited. Curr Opin Pulm Med. 2008 Nov;14(6):567-73. doi: 10.1097/MCP.0b013e32831311e8.
PubMed 18812834Shishodia S, Sethi G, Konopleva M, Andreeff M, Aggarwal BB. A synthetic triterpenoid, CDDO-Me, inhibits IkappaBalpha kinase and enhances apoptosis induced by TNF and chemotherapeutic agents through down-regulation of expression of nuclear factor kappaB-regulated gene products in human leukemic cells. Clin Cancer Res. 2006 Mar 15;12(6):1828-38. doi: 10.1158/1078-0432.CCR-05-2044.
PubMed 16551868Ahmad R, Raina D, Meyer C, Kharbanda S, Kufe D. Triterpenoid CDDO-Me blocks the NF-kappaB pathway by direct inhibition of IKKbeta on Cys-179. J Biol Chem. 2006 Nov 24;281(47):35764-9. doi: 10.1074/jbc.M607160200. Epub 2006 Sep 24.
PubMed 16998237Dinkova-Kostova AT, Liby KT, Stephenson KK, Holtzclaw WD, Gao X, Suh N, Williams C, Risingsong R, Honda T, Gribble GW, Sporn MB, Talalay P. Extremely potent triterpenoid inducers of the phase 2 response: correlations of protection against oxidant and inflammatory stress. Proc Natl Acad Sci U S A. 2005 Mar 22;102(12):4584-9. doi: 10.1073/pnas.0500815102. Epub 2005 Mar 14.
PubMed 15767573Liby K, Hock T, Yore MM, Suh N, Place AE, Risingsong R, Williams CR, Royce DB, Honda T, Honda Y, Gribble GW, Hill-Kapturczak N, Agarwal A, Sporn MB. The synthetic triterpenoids, CDDO and CDDO-imidazolide, are potent inducers of heme oxygenase-1 and Nrf2/ARE signaling. Cancer Res. 2005 Jun 1;65(11):4789-98. doi: 10.1158/0008-5472.CAN-04-4539.
PubMed 15930299Yates MS, Tauchi M, Katsuoka F, Flanders KC, Liby KT, Honda T, Gribble GW, Johnson DA, Johnson JA, Burton NC, Guilarte TR, Yamamoto M, Sporn MB, Kensler TW. Pharmacodynamic characterization of chemopreventive triterpenoids as exceptionally potent inducers of Nrf2-regulated genes. Mol Cancer Ther. 2007 Jan;6(1):154-62. doi: 10.1158/1535-7163.MCT-06-0516.
PubMed 17237276
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01315665
- Acronym / sponsor ID
- UHCMC-CFRC-2011-01
- Conditions
- Cystic Fibrosis
- Keywords
- broccoli sprouts, sulforaphane, triterpenoid, Nrf2 activation, cystic fibrosis, healthy volunteers, anti-inflammatory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Apr 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Posted 15 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Dietary Supplement: Broccoli sprouts100 grams of raw broccoli sprouts once daily for 5 consecutive days |
| Subjects with cystic fibrosis | Experimental | Dietary Supplement: Broccoli sprouts100 grams of raw broccoli sprouts once daily for 5 consecutive days |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broccoli sproutsAlso: sulforaphaneSubjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days. | Dietary supplement | Healthy volunteers, Subjects with cystic fibrosis |
Primary outcome
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)
4 secondary outcomes
Measures of Lipid Peroxidation in Nasal Epithelial Cells
Time frame: End of 5 day treatment period
Measures of Glutathione From Blood Lymphocytes
Time frame: Baseline and end of 5 day treatment period
Measures of Oxidative Stress in Urine
Time frame: Baseline and end of 5 day treatment period
Measure of Neutrophil Migration Into the Gingival Crevices
Time frame: Baseline and end of 5 day treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12162106Chmiel JF, Berger M, Konstan MW. The role of inflammation in the pathophysiology of CF lung disease. Clin Rev Allergy Immunol. 2002 Aug;23(1):5-27. doi: 10.1385/CRIAI:23:1:005.
- Background: PubMed 18846238Chen J, Kinter M, Shank S, Cotton C, Kelley TJ, Ziady AG. Dysfunction of Nrf-2 in CF epithelia leads to excess intracellular H2O2 and inflammatory cytokine production. PLoS One. 2008;3(10):e3367. doi: 10.1371/journal.pone.0003367. Epub 2008 Oct 10.
- Background: PubMed 19700644Nichols DP, Ziady AG, Shank SL, Eastman JF, Davis PB. The triterpenoid CDDO limits inflammation in preclinical models of cystic fibrosis lung disease. Am J Physiol Lung Cell Mol Physiol. 2009 Nov;297(5):L828-36. doi: 10.1152/ajplung.00171.2009. Epub 2009 Aug 21.
- Background: PubMed 17466952Verhaeghe C, Remouchamps C, Hennuy B, Vanderplasschen A, Chariot A, Tabruyn SP, Oury C, Bours V. Role of IKK and ERK pathways in intrinsic inflammation of cystic fibrosis airways. Biochem Pharmacol. 2007 Jun 15;73(12):1982-94. doi: 10.1016/j.bcp.2007.03.019. Epub 2007 Mar 24.
- Background: PubMed 12388360Li J, Johnson XD, Iazvovskaia S, Tan A, Lin A, Hershenson MB. Signaling intermediates required for NF-kappa B activation and IL-8 expression in CF bronchial epithelial cells. Am J Physiol Lung Cell Mol Physiol. 2003 Feb;284(2):L307-15. doi: 10.1152/ajplung.00086.2002. Epub 2002 Sep 27.
- Background: PubMed 12762338Escotte S, Tabary O, Dusser D, Majer-Teboul C, Puchelle E, Jacquot J. Fluticasone reduces IL-6 and IL-8 production of cystic fibrosis bronchial epithelial cells via IKK-beta kinase pathway. Eur Respir J. 2003 Apr;21(4):574-81. doi: 10.1183/09031936.03.00031803.
- Background: PubMed 17943753Lands LC, Stanojevic S. Oral non-steroidal anti-inflammatory drug therapy for cystic fibrosis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001505. doi: 10.1002/14651858.CD001505.pub2.
- Background: PubMed 17761616Flume PA, O'Sullivan BP, Robinson KA, Goss CH, Mogayzel PJ Jr, Willey-Courand DB, Bujan J, Finder J, Lester M, Quittell L, Rosenblatt R, Vender RL, Hazle L, Sabadosa K, Marshall B; Cystic Fibrosis Foundation, Pulmonary Therapies Committee. Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2007 Nov 15;176(10):957-69. doi: 10.1164/rccm.200705-664OC. Epub 2007 Aug 29.
- Background: PubMed 10208207Oermann CM, Sockrider MM, Konstan MW. The use of anti-inflammatory medications in cystic fibrosis: trends and physician attitudes. Chest. 1999 Apr;115(4):1053-8. doi: 10.1378/chest.115.4.1053.
- Background: PubMed 18812834Konstan MW. Ibuprofen therapy for cystic fibrosis lung disease: revisited. Curr Opin Pulm Med. 2008 Nov;14(6):567-73. doi: 10.1097/MCP.0b013e32831311e8.
- Background: PubMed 16551868Shishodia S, Sethi G, Konopleva M, Andreeff M, Aggarwal BB. A synthetic triterpenoid, CDDO-Me, inhibits IkappaBalpha kinase and enhances apoptosis induced by TNF and chemotherapeutic agents through down-regulation of expression of nuclear factor kappaB-regulated gene products in human leukemic cells. Clin Cancer Res. 2006 Mar 15;12(6):1828-38. doi: 10.1158/1078-0432.CCR-05-2044.
- Background: PubMed 16998237Ahmad R, Raina D, Meyer C, Kharbanda S, Kufe D. Triterpenoid CDDO-Me blocks the NF-kappaB pathway by direct inhibition of IKKbeta on Cys-179. J Biol Chem. 2006 Nov 24;281(47):35764-9. doi: 10.1074/jbc.M607160200. Epub 2006 Sep 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James F. Chmiel, MD, MPH principal investigator
Rainbow Babies and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broccoli sprouts in people with Cystic Fibrosis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nrf2 Activation in Nasal Epithelial Cells (time frame: Baseline and of end of 5 day treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315665, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.