AsthmaNCT01183923
Dietary Interventions in Asthma Treatment: Sprouts Study
A study testing Broccoli Sprouts and Alfalfa Sprouts in people with Asthma and Allergy, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- What is being tested?
- Broccoli Sprouts and Alfalfa Sprouts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 6 Feb 2012
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-49 years
- Physician-diagnosed asthma
- No other major pulmonary disease such as cystic fibrosis or chronic obstructive pulmonary disease (COPD)
- Mouse sensitization, defined by a positive skin prick test to mouse epithelial extract or positive mouse-specific immunoglobulin E (IgE)
- Non-smoker
Who cannot join
- Severe or unstable asthma defined as requiring hospitalization in the previous year or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
- Baseline FEV1 and FEV1/forced vital capacity (FVC) < 70% predicted
- Positive skin prick test (SPT) to a pet currently living in the participant's home
- Other significant medical issues such as heart disease or poorly controlled hypertension, or hypothyroidism
- Pregnancy or nursing/breastfeeding mothers
- On beta-blocker therapy
Show all 12Show fewer
- Taking anti-oxidant supplements
- Unable to stop antihistamines prior to skin testing
- Unable to stop medications that may interfere with allergen challenge responses prior to challenges.
- The participant has food allergy to BS or AS.
- Omalizumab use within the last 12 months.
- Oral corticosteroid use within the last 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Broccoli Sprouts, Alfalfa Sprouts
- Keywords
- asthma, dietary interventions, mouse allergy
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli SproutsOther
Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.
Alfalfa SproutsOther
Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts.
| Study group | Role | What they receive |
|---|---|---|
| Broccoli Sprouts, then Alfalfa Sprouts | Experimental | Broccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout. Receives: Other: Broccoli Sprouts; Other: Alfalfa Sprouts |
| Alfalfa Sprouts, then Broccoli Sprouts | Experimental | Alfalfa Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by broccoli sprouts after washout. Receives: Other: Broccoli Sprouts; Other: Alfalfa Sprouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startNov 2010
- Primary completion6 Feb 2012
- Study completion6 Feb 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS), Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Elizabeth C Matsui, MD MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183923
- Sponsor's protocol ID
- NA_00035087
- Other IDs
- 1P01ES018176-01
- Status last verified
- May 2019
- First submitted
- 17 Aug 2010
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27130714
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Interventions in Asthma Treatment: Sprouts Study
- ClinicalTrials.gov ID
- NCT01183923
- Acronym / sponsor ID
- NA_00035087
- Keywords
- asthma, dietary interventions, mouse allergy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS), Massachusetts General Hospital
- Study start
- Nov 2010
- Primary completion
- 6 Feb 2012 (actual)
- Study completion
- 6 Feb 2012 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Broccoli Sprouts, then Alfalfa Sprouts | Experimental | Other: Broccoli Sprouts, Other: Alfalfa SproutsBroccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout. |
| Alfalfa Sprouts, then Broccoli Sprouts | Experimental | Other: Broccoli Sprouts, Other: Alfalfa SproutsAlfalfa Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by broccoli sprouts after washout. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-49 years
- Physician-diagnosed asthma
- No other major pulmonary disease such as cystic fibrosis or chronic obstructive pulmonary disease (COPD)
- Mouse sensitization, defined by a positive skin prick test to mouse epithelial extract or positive mouse-specific immunoglobulin E (IgE)
- Non-smoker
Key exclusion criteria (12 listed)
- Severe or unstable asthma defined as requiring hospitalization in the previous year or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
- Baseline FEV1 and FEV1/forced vital capacity (FVC) < 70% predicted
- Positive skin prick test (SPT) to a pet currently living in the participant's home
- Other significant medical issues such as heart disease or poorly controlled hypertension, or hypothyroidism
- Pregnancy or nursing/breastfeeding mothers
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 SproutsBroccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts. | Other | Alfalfa Sprouts, then Broccoli Sprouts, Broccoli Sprouts, then Alfalfa Sprouts |
| Alfalfa SproutsAlfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts. | Other | Alfalfa Sprouts, then Broccoli Sprouts, Broccoli Sprouts, then Alfalfa Sprouts |
Primary outcome
Change in Forced Expiratory Volume at One Second (FEV1)
Time frame: 30 days
The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27130714Sudini 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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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.
Elizabeth C Matsui, MD MHS principal investigator
Johns Hopkins University
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 and Alfalfa Sprouts in people with Asthma and Allergy, run by Johns Hopkins University 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Jun 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 4 Jun 2019). 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?
Change in Forced Expiratory Volume at One Second (FEV1) (time frame: 30 days). 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 NCT01183923, which also lists 1 linked publication.
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 4 Jun 2019.