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| ID | Type | Description | Link |
|---|---|---|---|
| 1P01ES018176-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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The primary objective of this study is to determine if broccoli sprouts (BS) improves airway inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen sensitization.
The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Broccoli Sprouts | Experimental | Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days |
|
| Alfalfa Sprouts | Placebo Comparator | Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Broccoli Sprouts | Drug | 100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Nitric Oxide Concentrations | exhaled nitric oxide concentrations | at 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Matsui, MD, MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Broccoli Sprouts | ingestion of broccoli sprouts 3 consecutive days |
| FG001 | Alfalfa Sprouts (Placebo Control) | ingestion of alfalfa sprouts 3 consecutive days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Broccoli Sprouts | |
| BG001 | Alfalfa Sprouts (Placebo Control) | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Exhaled Nitric Oxide Concentrations | exhaled nitric oxide concentrations | Posted | Median | Inter-Quartile Range | ppb | at 3 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 | Broccoli Sprouts |
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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 |
|---|---|
| D065631 | Rhinitis, Allergic |
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Placebo | Drug | Alfalfa Sprouts |
|
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Total of all reporting groups
| years |
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| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Alfalfa Sprouts (Placebo Control) | 0 | 20 | 0 | 20 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |