Allergic RhinitisNCT01522703
Effects of Whole Sprouts on Airway Allergic Inflammation
A study testing Broccoli Sprouts in people with Allergic Rhinitis and Asthma, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis, Asthma, Allergy
- What is being tested?
- Broccoli Sprouts
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2015
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- doctor diagnosis of asthma
- aeroallergen sensitization
- Non-smoker
- Negative pregnancy test
- Not breastfeeding
- Normal TSH
Show all 10Show fewer
- For women, abstinent or using reliable birth control
- Age 18-50 years
- No other major pulmonary disease such as cystic fibrosis or COPD
- Willingness to participate in study and sign consent form
Who cannot join
- Severe or unstable asthma defined as requiring hospitalization in the previous 6 months or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
- Uncontrolled asthma defined as short-acting beta agonist use 3 or more days a week in the previous 4 weeks
- Other significant medical issues such as heart disease or poorly controlled hypertension, type 1 diabetes, poorly controlled type 2 diabetes, or hypothyroidism
- Pregnancy or nursing/breastfeeding mothers
- On beta-blocker therapy
- On reserpine, clonidine, imipramine, or related tricyclic drugs
Show all 12Show fewer
- Taking anti-oxidant supplements
- Planned dietary changes during the study period
- Unable to stop antihistamines prior to skin testing
- Food allergy to Broccoli Sprouts or Alfalfa Sprouts
- Omalizumab use within the last 12 months
- Nasal polyps
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation
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.
- Conditions
- Allergic Rhinitis, Asthma, Allergy
- Being tested
- Broccoli Sprouts, Placebo
- Keywords
- asthma, allergic rhinitis, dietary interventions, mouse allergy
- Medical subject headings
- Rhinitis, Allergic, Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli SproutsDrug
Also called sprouts, broccoli sprouts
100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.
PlaceboDrug
Also called sprouts, alfalfa, broccoli sprouts
Alfalfa Sprouts
| Study group | Role | What they receive |
|---|---|---|
| Broccoli Sprouts | Experimental | Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days Receives: Drug: Broccoli Sprouts |
| Alfalfa Sprouts | Placebo comparator | Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Nitric Oxide Concentrations
exhaled nitric oxide concentrations
Measured: at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionMar 2015
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.
- Other trials for Allergic RhinitisStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Elizabeth Matsui, Johns Hopkins University
- Investigators
- Elizabeth Matsui, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522703
- Sponsor's protocol ID
- NA_00067371
- Other IDs
- 1P01ES018176-01
- Status last verified
- Oct 2016
- First submitted
- 9 Jan 2012
- Last updated
- 19 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation
- ClinicalTrials.gov ID
- NCT01522703
- Acronym / sponsor ID
- NA_00067371
- Conditions
- Allergic Rhinitis, Asthma, Allergy
- Keywords
- asthma, allergic rhinitis, dietary interventions, mouse allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Mar 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 19 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Broccoli Sprouts | Experimental | Drug: Broccoli SproutsBroccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days |
| Alfalfa Sprouts | Placebo comparator | Drug: PlaceboAlfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- doctor diagnosis of asthma
- aeroallergen sensitization
- Non-smoker
- Negative pregnancy test
- Not breastfeeding
Key exclusion criteria (12 listed)
- Severe or unstable asthma defined as requiring hospitalization in the previous 6 months or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
- Uncontrolled asthma defined as short-acting beta agonist use 3 or more days a week in the previous 4 weeks
- Other significant medical issues such as heart disease or poorly controlled hypertension, type 1 diabetes, poorly controlled type 2 diabetes, or hypothyroidism
- Pregnancy or nursing/breastfeeding mothers
- On beta-blocker therapy
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: sprouts, broccoli sprouts100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form. | Drug | Broccoli Sprouts |
| PlaceboAlso: sprouts, alfalfa, broccoli sproutsAlfalfa Sprouts | Drug | Alfalfa Sprouts |
Primary outcome
Exhaled Nitric Oxide Concentrations
Time frame: at 3 days
exhaled nitric oxide concentrations
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 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 in people with Allergic Rhinitis and Asthma, 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 10 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: finished, as of the sponsor's last update on 19 Jan 2017. 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. Some participants in this study may receive a placebo. 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 19 Jan 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?
Exhaled Nitric Oxide Concentrations (time frame: at 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2017.