AsthmaNCT00277446
Dietary Supplementation With Soy Isoflavones in Asthma
A study testing Soy isoflavones in people with Asthma, run by Northwestern University at 1 site in United States.
Trial summary
An epidemiologic study of patients with asthma has shown that increased intake of soy isoflavones correlates with less severe asthma. In experimental animals, treatment with the soy isoflavone genistein reduces airways inflammation and hyper-responsiveness. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Soy isoflavones
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 2007
- 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
- Ages 18-50, males and females
- Physician diagnosis of asthma; requires daily asthma medication
- Moderate persistent disease (NAEPP guidelines)
- FEV1 65 to 90% of predicted
- At least 12% increase in FEV1 15-30 minutes after inhaling 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 8 mg/ml) - either of these can available from the previous 2 years
- Generally good health
Who cannot join
- Oral corticosteroid use within the past 3 months
- Use of high dose inhaled corticosteroids (greater than 500 mcg of fluticasone per day or greater)
- Current or former smoker (quit less than 6 months prior to study enrollment or greater than 10 pack years)
- Recent asthma exacerbation (within 6 weeks)
- Current consumption of soy isoflavone supplements
- Known adverse reaction to genistein, other phytoestrogens, or soy products
Show all 10Show fewer
- Pregnant
- Unintentional weight loss of more than 10 pounds within the year
- Major or unstable medical condition
- Use of an investigational drug in the previous 30 days
Trial locations and contacts
1 site in 1 country.
About this study
An epidemiologic study of patients with asthma has shown that increased intake of soy isoflavones correlates with less severe asthma. In experimental animals, treatment with the soy isoflavone genistein reduces airways inflammation and hyper-responsiveness. In vitro studies performed by us have shows that genistein reduces release of inflammatory compounds by human blood eosinophils. The purpose of this pilot study is to determine whether dietary supplementation with soy isoflavones has effects in patients with asthma. 20 patients with asthma will supplement their diet with a soy isoflavone capsule for 4 weeks. Before and after the supplementation period, we will measure lung function, exhaled nitric oxide (a marker for airway inflammation), collect exhaled breath condensate to measure levels of inflammatory mediators in the airways, and isolate peripheral blood eosinophils to assess the impact of soy isoflavones on their function. We hypothesize that dietary supplementation with soy isoflavones will reduce exhaled nitric oxide level, reduce the inflammatory mediators in the exhaled breath condensate, and reduce the ability of eosinophils to release inflammatory molecules. Identifying if these hypothesized effects of soy isoflavones exist in asthma will provide a justification for further clinical studies.
Read the detailed description
This is a prospective pilot study to be conducted in 20 subjects with asthma. The participant will undergo the following procedures:
- Completion of a questionnaire that asks for information about asthma including symptoms, medications, and ability to participate in activities.
- Measurement of exhaled nitric oxide (NO) in which subjects will breathe slowly into a tube. This test takes about 5 minutes.
- Collection of the air exhaled from the lungs and condensing it into a liquid form. This is called an exhaled breath condensate. This procedure involves breathing slowing into a tube for a period of 15 minutes. The measurements determined by this method are exclusively for research purposes and not used in routine clinical settings.
- Measurement of lung function with a spirometer. This involves breathing in and out forcefully through a mouthpiece.
- Collection of 60 ml (4 tablespoons) of blood to measure genistein (the major component of the soy isoflavone) levels and eosinophil function. These measurements are also for research purposes and not routinely used clinically.
Each of the above measurements will be made before and after the 4 week period of dietary supplementation with soy isoflavones.
- Conditions
- Asthma
- Being tested
- Soy isoflavones
- Keywords
- Asthma, Soy isoflavones, Eosinophils, Exhaled nitric oxide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy isoflavonesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Nitric Oxide
Exhaled nitric oxide at baseline (week 0) and at 4 weeks
Measured: 0 and 4 weeks
Secondary outcomes (2)
Eosinophil LTC4 Synthesis
Peripheral blood eosinophils were isolated before and after treatment with Novasoy, stimulated with calcium ionophore, and the amount of leukotriene C4 (LTC4) produced was measured by EIA.
Measured: 0 and 4 weeks
Forced Expiratory Volume in One Second (FEV1)
Forced expiratory volume in one second (FEV1) measured as liters/second
Measured: 0 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2007
- Study completionApr 2007
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 AsthmaStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Investigators
- Lewis J Smith, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277446
- Sponsor's protocol ID
- 0456-035
- Status last verified
- Feb 2011
- First submitted
- 13 Jan 2006
- Last updated
- 25 Feb 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplementation With Soy Isoflavones in Asthma
- ClinicalTrials.gov ID
- NCT00277446
- Acronym / sponsor ID
- 0456-035
- Conditions
- Asthma
- Keywords
- Asthma, Soy isoflavones, Eosinophils, Exhaled nitric oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Posted 24 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An epidemiologic study of patients with asthma has shown that increased intake of soy isoflavones correlates with less severe asthma. In experimental animals, treatment with the soy isoflavone genistein reduces airways inflammation and hyper-responsiveness. In vitro studies performed by us have shows that genistein reduces release of inflammatory compounds by human blood eosinophils. The purpose of this pilot study is to determine whether dietary supplementation with soy isoflavones has effects in patients with asthma. 20 patients with asthma will supplement their diet with a soy isoflavone capsule for 4 weeks. Before and after the supplementation period, we will measure lung function, exhaled nitric oxide (a marker for airway inflammation), collect exhaled breath condensate to measure levels of inflammatory mediators in the airways, and isolate peripheral blood eosinophils to assess the impact of soy isoflavones on their function. We hypothesize that dietary supplementation with soy isoflavones will reduce exhaled nitric oxide level, reduce the inflammatory mediators in the exhaled breath condensate, and reduce the ability of eosinophils to release inflammatory molecules. Identifying if these hypothesized effects of soy isoflavones exist in asthma will provide a justification for further clinical studies.
Detailed description
This is a prospective pilot study to be conducted in 20 subjects with asthma. The participant will undergo the following procedures:
- Completion of a questionnaire that asks for information about asthma including symptoms, medications, and ability to participate in activities.
- Measurement of exhaled nitric oxide (NO) in which subjects will breathe slowly into a tube. This test takes about 5 minutes.
- Collection of the air exhaled from the lungs and condensing it into a liquid form. This is called an exhaled breath condensate. This procedure involves breathing slowing into a tube for a period of 15 minutes. The measurements determined by this method are exclusively for research purposes and not used in routine clinical settings.
- Measurement of lung function with a spirometer. This involves breathing in and out forcefully through a mouthpiece.
- Collection of 60 ml (4 tablespoons) of blood to measure genistein (the major component of the soy isoflavone) levels and eosinophil function. These measurements are also for research purposes and not routinely used clinically.
Each of the above measurements will be made before and after the 4 week period of dietary supplementation with soy isoflavones.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ages 18-50, males and females
- Physician diagnosis of asthma; requires daily asthma medication
- Moderate persistent disease (NAEPP guidelines)
- FEV1 65 to 90% of predicted
- At least 12% increase in FEV1 15-30 minutes after inhaling 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 8 mg/ml) - either of these can available from the previous 2 years
Key exclusion criteria (10 listed)
- Oral corticosteroid use within the past 3 months
- Use of high dose inhaled corticosteroids (greater than 500 mcg of fluticasone per day or greater)
- Current or former smoker (quit less than 6 months prior to study enrollment or greater than 10 pack years)
- Recent asthma exacerbation (within 6 weeks)
- Current consumption of soy isoflavone supplements
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 |
|---|---|---|
| Soy isoflavones | Drug | – |
Primary outcome
Exhaled Nitric Oxide
Time frame: 0 and 4 weeks
Exhaled nitric oxide at baseline (week 0) and at 4 weeks
2 secondary outcomes
Eosinophil LTC4 Synthesis
Time frame: 0 and 4 weeks
Forced Expiratory Volume in One Second (FEV1)
Time frame: 0 and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2011.
- 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.
Lewis J Smith, MD principal investigator
Northwestern 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 Soy isoflavones in people with Asthma, run by Northwestern 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 6 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 25 Feb 2011. 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 24 Feb 2011). 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 (time frame: 0 and 4 weeks). 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 25 Feb 2011.