AsthmaPhase 1brasmaNCT01845493
Sulforaphane Supplementation in Atopic Asthmatics
A Phase 1 study testing Alpha Sprout Homogenate and Sulforaphane Homogenate in people with Asthma, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The investigators will perform a pilot study of daily treatment with oral sulforaphane (SFN) for 3 days to determine if Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induction is possible with this supplementation regimen in individuals with allergic asthma. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Alpha Sprout Homogenate and Sulforaphane Homogenate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age 18-50 of both genders
- History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years.
- AND: Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine). Methacholine challenge in a separate screening protocol (98-0799), or from other venues will be accepted.
- OR: Pre and post bronchodilator FEV1 improvement by 12% or more after 4 puffs of albuterol inhaler.
- FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma (NHANES III predicted set).
- Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response in a separate screening protocol. Proof of allergy from other venues, including ImmunoCAP testing from a medical workup, provided by the subject, will be accepted.
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- Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg)
- Willing to provide information regarding health history and habits of cigarette smoke exposure;
- Willing to avoid antioxidant vitamins and cruciferous vegetables as well as juices/drinks with added vitamin supplements for 2 days prior the baseline screening visit and throughout initial dosing period.
- Subjects must be willing to avoid antihistamine use for 4 days prior to each session and NSAIDs for 7 days prior to each session. Nasal steroids must be held for 2 weeks prior to the session.
Who cannot join
- Medical history or underlying health problems that preclude participation in the protocol per the study physician;
- Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc;
- Use of oral corticosteroids within the past 4 weeks;
- Presence of upper or lower respiratory tract infection or treatment with antibiotics within the previous 4 weeks;
- Pregnancy as determined by menstrual history or urine pregnancy test;
- Current smokers will be excluded. Anyone with a smoking history > 0.5 pack year and/or >1 pack per month will also be excluded.
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- History of bleeding disorder;
- Recent nasal surgery (with 6 months). If a subject has had nasal surgery between 6 months and 5 years, a study physician will visualize the area prior to the biopsy to evaluate the suitability of the nose for the procedure.
- History of intolerance of or aversion to broccoli
- Unable to withhold nasal steroids for 2 weeks before each session. These subjects may be deferred until after their allergy season.
Trial locations and contacts
1 site in 1 country.
United States1 site
Environmental Protection Agency at the University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
The investigators will perform a pilot study of daily treatment with oral sulforaphane (SFN) for 3 days to determine if Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induction is possible with this supplementation regimen in individuals with allergic asthma.
Read the detailed description
This pilot study will examine if oral SFN supplementation can induce NRF2 and NRF2-dependent phase II enzymes in nasal epithelial cells of allergic asthmatics. Subjects will receive both a SFN-rich broccosprout homogenate preparation and an alfalfa sprout homogenate (placebo) in a crossover fashion. mRNA levels of NRF2 and NRF2-dependent phase II enzymes will be compared between the active and placebo periods.
- Conditions
- Asthma
- Being tested
- Alpha Sprout Homogenate, Sulforaphane Homogenate
- Keywords
- asthma, Asthmatics, allergic, allergies
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Sprout HomogenateDietary supplement
Also called Placebo
Alpha Sprout Homogenate
Sulforaphane HomogenateDietary supplement
Active
| Study group | Role | What they receive |
|---|---|---|
| Sulforaphane-rich supplement | Active comparator | Intervention: broccosprout homogenate (rich in Sulforaphane) taken orally daily x 3 days Receives: Dietary Supplement: Sulforaphane Homogenate |
| Alfalfa Sprout Homogenate | Placebo comparator | Placebo: Alfalfa sprout homogenate taken daily x 3 days (poor in sulforaphane) Receives: Dietary Supplement: Alpha Sprout Homogenate |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA levels of NRF2 and NRF2-dependent phase II enzymes in nasal epithelial cells
Measured: 2 hours post third ingestion of SFN/placebo ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Hernandez, MD, University of North Carolina, Chapel Hill
- Investigators
- Michelle L Hernandez, MD, Principal investigator, center for environmental medicine asthma and lung biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845493
- Sponsor's protocol ID
- 13-0056
- Acronym
- brasma
- Status last verified
- Mar 2016
- First submitted
- 17 Apr 2013
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sulforaphane Supplementation in Atopic Asthmatics
- ClinicalTrials.gov ID
- NCT01845493
- Acronym / sponsor ID
- brasma / 13-0056
- Conditions
- Asthma
- Keywords
- asthma, Asthmatics, allergic, allergies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will perform a pilot study of daily treatment with oral sulforaphane (SFN) for 3 days to determine if Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induction is possible with this supplementation regimen in individuals with allergic asthma.
Detailed description
This pilot study will examine if oral SFN supplementation can induce NRF2 and NRF2-dependent phase II enzymes in nasal epithelial cells of allergic asthmatics. Subjects will receive both a SFN-rich broccosprout homogenate preparation and an alfalfa sprout homogenate (placebo) in a crossover fashion. mRNA levels of NRF2 and NRF2-dependent phase II enzymes will be compared between the active and placebo periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulforaphane-rich supplement | Active comparator | Dietary Supplement: Sulforaphane HomogenateIntervention: broccosprout homogenate (rich in Sulforaphane) taken orally daily x 3 days |
| Alfalfa Sprout Homogenate | Placebo comparator | Dietary Supplement: Alpha Sprout HomogenatePlacebo: Alfalfa sprout homogenate taken daily x 3 days (poor in sulforaphane) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 18-50 of both genders
- History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years.
- AND: Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine). Methacholine challenge in a separate screening protocol (98-0799), or from other venues will be accepted.
- OR: Pre and post bronchodilator FEV1 improvement by 12% or more after 4 puffs of albuterol inhaler.
- FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma (NHANES III predicted set).
Key exclusion criteria (10 listed)
- Medical history or underlying health problems that preclude participation in the protocol per the study physician;
- Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc;
- Use of oral corticosteroids within the past 4 weeks;
- Presence of upper or lower respiratory tract infection or treatment with antibiotics within the previous 4 weeks;
- Pregnancy as determined by menstrual history or urine pregnancy test;
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 |
|---|---|---|
| Alpha Sprout HomogenateAlso: PlaceboAlpha Sprout Homogenate | Dietary supplement | Alfalfa Sprout Homogenate |
| Sulforaphane HomogenateActive | Dietary supplement | Sulforaphane-rich supplement |
Primary outcome
mRNA levels of NRF2 and NRF2-dependent phase II enzymes in nasal epithelial cells
Time frame: 2 hours post third ingestion of SFN/placebo ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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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.
Michelle L Hernandez, MD principal investigator
center for environmental medicine asthma and lung biology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alpha Sprout Homogenate and Sulforaphane Homogenate in people with Asthma, run by University of North Carolina, Chapel Hill 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 10 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 9 Mar 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mRNA levels of NRF2 and NRF2-dependent phase II enzymes in nasal epithelial cells (time frame: 2 hours post third ingestion of SFN/placebo ingestion). 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 9 Mar 2016.