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| ID | Type | Description | Link |
|---|---|---|---|
| 1P01ES018176-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
| Massachusetts General Hospital | OTHER |
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Sulforaphane (SFN) is a naturally occurring isothiocyanate that is a potent inducer of Phase II enzymes which play a critical role in preventing oxidative stress (via activation of Nrf2). Broccoli sprouts (BS) contain the richest source of SFN.
The main objectives of this study are to test the effect of broccoli sprouts (BS) on biomarkers of oxidative stress (OS), inflammation, basophil activation, and clinical outcomes in mouse allergen-induced asthma by (1) determining if BS improves lung function and airways symptom responses in mouse-sensitized adults with asthma undergoing environmental mouse allergen challenge (EMAC), (2) examining the effect of BS on OS, inflammation, and basophil activation, and (3) examining the effect of BS on changes in OS, inflammation, and basophil activation after EMAC.
After eligibility is confirmed, participants will be randomized to (a) placebo then BS or (b) BS then placebo. At randomization, baseline exhaled nitric oxide (eNO), forced expiratory volume at one second (FEV1), nasal epithelial gene expression, urinary OS biomarkers, serum inflammatory and OS biomarkers, and basophil activation will be assessed. These will be assessed again after 7 days on the assigned intervention at two time points: pre- and post-EMAC. The 1 week time period was chosen because previous studies have shown that daily ingestion of a broccoli sprout homogenate for three days resulted in upregulation of phase II enzyme gene expression in nasal epithelial cells. Following a 2-week washout period, this protocol will be repeated for the second intervention, phase II. The 2 week washout period will be sufficient as the half life of the extract of the active ingredient in broccoli sprouts, SFN, has been shown to be 1.8 hours.(16) Participants' diets will be assessed before and after each intervention with a Food Frequency Questionnaire and a questionnaire to capture intake of specific foods that are rich in SFN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Broccoli Sprouts, then Alfalfa Sprouts | Experimental | Broccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout. |
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| Alfalfa Sprouts, then Broccoli Sprouts | Experimental | Alfalfa Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by broccoli sprouts after washout. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Broccoli Sprouts | Other | Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume at One Second (FEV1) | The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth C Matsui, MD MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27130714 | Derived | Sudini K, Diette GB, Breysse PN, McCormack MC, Bull D, Biswal S, Zhai S, Brereton N, Peng RD, Matsui EC. A Randomized Controlled Trial of the Effect of Broccoli Sprouts on Antioxidant Gene Expression and Airway Inflammation in Asthmatics. J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):932-40. doi: 10.1016/j.jaip.2016.03.012. Epub 2016 Apr 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Broccoli Sprouts, Then Alfalfa Sprouts | Broccoli Sprouts will be eaten daily in a sandwich form, followed by a 14 day washout, and then alfalfa sprouts will be eaten daily in a sandwich form. |
| FG001 | Alfalfa Sprouts, Then Broccoli Sprouts | Alfalfa sprouts will be eaten daily in a sandwich form, followed by a 14 day washout, and then broccoli sprouts will be eaten daily in a sandwich form. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 (7 Days) |
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| Washout (14 Days) |
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| Intervention 2 (7 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | the study population will be randomized in a 1:1 ratio to first eat broccoli sprouts followed by a washout period and then eat alfalfa sprouts, or to start with alfalfa sprouts followed by a washout and then eat broccoli sprouts |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Forced Expiratory Volume at One Second (FEV1) | The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure. | Trial was halted due to an adverse event after the second intervention. The participant could not complete the second challenge for data to be obtained. | Posted | Number | percent change | 30 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Study Population | Total population, which is randomized 1:1 to broccoli sprouts, then alfalfa sprouts or alfalfa sprouts, then broccoli sprouts |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Matsui, MD MHS | Johns Hopkins University School of Medicine | 410-502-3858 | ematsui@jhmi.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Alfalfa Sprouts | Other | Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 1 |
| 1 |
| 1 |
| 0 |
| 1 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |