AsthmaNCT00741208
Modification of Asthma With Soy Isoflavone
A study testing Soy Isoflavone in people with Asthma, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to determine if dietary supplementation with soy isoflavones in persistent asthma improves airway reactivity as determined by PC20 to methacholine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Soy Isoflavone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Nov 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- Physician diagnosed asthma;
- Positive methacholine bronchoprovocation test (20% fall in FEV1 at less than 8 mg/ml) with the past 3 years;
- Smoking Status: non-smoker for 6 months or longer and a less than 10 pack-year cumulative smoking history.
Who cannot join
- Pulmonary function FEV1< 70% predicted pre-bronchodilator;
- Other major chronic illness: conditions that in the judgement of athe principle investigator would interfere with participation in the study or history of or physician diagnosis of COPD, emphysema, or chronic bronchitis;
- Medication use: current consumption of soy isoflavone supplements or oral corticosteroid use within the past 6 months OR use of an investigational treatment within the previous 30 days;
- Drug allergy: known adverse reaction to genistein, other phytoestrogens, or soy products;
- Females of childbearing potential: pregnant or lactating or women of appropriate ago who report the possibility of pregnancy at the time of enrollment will be screened and cannot participate if pregnant;
- Non-adherence: inability or unwillingness to provide informed consent or inability to swallow study medication or inability to perform baseline measurements or completion of fewer than 5 of the 7 days of screening period diary entry or inability to be contacted by telephone;
- Other exclusions: recent asthma exacerbation (within 6 weeks) or recent upper respiratory tract infection (within 2 weeks) or change in diet over the past 1 month or expected change in diet (for example a weight loss diet) during the 6 week study period.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if dietary supplementation with soy isoflavones in persistent asthma improves airway reactivity as determined by PC20 to methacholine.
Read the detailed description
Asthma is a complex disease whose prevalence and severity are determined by multiple genetic and environmental factors. The prevalence of asthma has increased during the past few decades. Although causal relationships have not been proven, changing dietary practices have paralleled the increase in asthma prevalence. Several surveys have found an association between reduced lung function and decreased consumption of antioxidants, flavonoids, and essential vitamins in a variety of respiratory conditions including asthma. These findings suggest that diet may be a factor that impacts asthma and its clinical manifestations.
Higher dietary consumption of soy isoflavones is associated with decreased self-report of cough and other allergic respiratory symptoms. Our group reported an inverse relationship between dietary intake of the soy isoflavone genistein and asthma severity. In addition, we recently demonstrated that genistein inhibits synthesis of cysteinyl-leukotrienes in eosinophils by blocking p38-dependent activation of 5-lipoxygenase, providing a plausible cellular mechanism for the benefit of soy isoflavones in asthma. We also documented that dietary soy isoflavone supplementation in asthma patients inhibited eosinophil cysteinyl-leukotriene synthesis and decreased exhaled nitric oxide, an indicator of eosinophilic airway inflammation. Our overall long-term goal is to translate these epidemiological and mechanistic findings to human disease and determine whether dietary soy isoflavones have a clinical role in asthma. We propose a clinical study powered to detect an improvement in lung function as the first stop in achieving this goal.
Our hypothesis is that dietary supplementation with isoflavones will improve lung function, reduce symptoms, and decrease airway inflammation in asthma. To test this, we will conduct a randomized placebo-controlled, cross-over study of soy isoflavone supplementation in patients with persistent asthma.
- Conditions
- Asthma
- Being tested
- Soy Isoflavone
- Keywords
- asthma, soy isoflavone, genistein, soy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy IsoflavoneDietary supplement
50mg soy isoflavone supplement consumed twice daily for a total of 100mg of soy isoflavones per day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Patients randomized to receive soy isoflavone twice daily for 2 weeks. Patients will cross-over and receive placebo medication for 2 weeks later in the study Receives: Dietary Supplement: Soy Isoflavone |
| 2 | Other | Patients randomized to receive placebo medication twice daily for 2 weeks. Patients will cross-over and receive soy isoflavone for 2 weeks later in the study Receives: Dietary Supplement: Soy Isoflavone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in airway reactivity induced by dietary supplementation with soy isoflavones. Airway reactivity will be measured with methacholine bronchoprovocation testing.
Measured: 6 weeks
Secondary outcomes (1)
Change in FEV1, morning peak flow rate, asthma control, markers of airway hyperreactivity and inflammation including sputum eosinophilia and eosinophilic cationic protein, fraction of expired nitric oxide, and urinary leukotriene.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2010
- Study completionNov 2010
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.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Respiratory Health Association of Metropolitan Chicago
- Investigators
- Ravi Kalhan, MD, MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741208
- Sponsor's protocol ID
- 2804
- Status last verified
- Jun 2011
- First submitted
- 22 Aug 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Asthma With Soy Isoflavone
- ClinicalTrials.gov ID
- NCT00741208
- Acronym / sponsor ID
- 2804
- Conditions
- Asthma
- Keywords
- asthma, soy isoflavone, genistein, soy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Respiratory Health Association of Metropolitan Chicago
- Study start
- Aug 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 26 Aug 2008 (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 purpose of this study is to determine if dietary supplementation with soy isoflavones in persistent asthma improves airway reactivity as determined by PC20 to methacholine.
Detailed description
Asthma is a complex disease whose prevalence and severity are determined by multiple genetic and environmental factors. The prevalence of asthma has increased during the past few decades. Although causal relationships have not been proven, changing dietary practices have paralleled the increase in asthma prevalence. Several surveys have found an association between reduced lung function and decreased consumption of antioxidants, flavonoids, and essential vitamins in a variety of respiratory conditions including asthma. These findings suggest that diet may be a factor that impacts asthma and its clinical manifestations.
Higher dietary consumption of soy isoflavones is associated with decreased self-report of cough and other allergic respiratory symptoms. Our group reported an inverse relationship between dietary intake of the soy isoflavone genistein and asthma severity. In addition, we recently demonstrated that genistein inhibits synthesis of cysteinyl-leukotrienes in eosinophils by blocking p38-dependent activation of 5-lipoxygenase, providing a plausible cellular mechanism for the benefit of soy isoflavones in asthma. We also documented that dietary soy isoflavone supplementation in asthma patients inhibited eosinophil cysteinyl-leukotriene synthesis and decreased exhaled nitric oxide, an indicator of eosinophilic airway inflammation. Our overall long-term goal is to translate these epidemiological and mechanistic findings to human disease and determine whether dietary soy isoflavones have a clinical role in asthma. We propose a clinical study powered to detect an improvement in lung function as the first stop in achieving this goal.
Our hypothesis is that dietary supplementation with isoflavones will improve lung function, reduce symptoms, and decrease airway inflammation in asthma. To test this, we will conduct a randomized placebo-controlled, cross-over study of soy isoflavone supplementation in patients with persistent asthma.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Dietary Supplement: Soy IsoflavonePatients randomized to receive soy isoflavone twice daily for 2 weeks. Patients will cross-over and receive placebo medication for 2 weeks later in the study |
| 2 | Other | Dietary Supplement: Soy IsoflavonePatients randomized to receive placebo medication twice daily for 2 weeks. Patients will cross-over and receive soy isoflavone for 2 weeks later in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older;
- Physician diagnosed asthma;
- Positive methacholine bronchoprovocation test (20% fall in FEV1 at less than 8 mg/ml) with the past 3 years;
- Smoking Status: non-smoker for 6 months or longer and a less than 10 pack-year cumulative smoking history.
Key exclusion criteria (7 listed)
- Pulmonary function FEV1< 70% predicted pre-bronchodilator;
- Other major chronic illness: conditions that in the judgement of athe principle investigator would interfere with participation in the study or history of or physician diagnosis of COPD, emphysema, or chronic bronchitis;
- Medication use: current consumption of soy isoflavone supplements or oral corticosteroid use within the past 6 months OR use of an investigational treatment within the previous 30 days;
- Drug allergy: known adverse reaction to genistein, other phytoestrogens, or soy products;
- Females of childbearing potential: pregnant or lactating or women of appropriate ago who report the possibility of pregnancy at the time of enrollment will be screened and cannot participate if pregnant;
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 Isoflavone50mg soy isoflavone supplement consumed twice daily for a total of 100mg of soy isoflavones per day. | Dietary supplement | 1, 2 |
Primary outcome
Change in airway reactivity induced by dietary supplementation with soy isoflavones. Airway reactivity will be measured with methacholine bronchoprovocation testing.
Time frame: 6 weeks
1 secondary outcome
Change in FEV1, morning peak flow rate, asthma control, markers of airway hyperreactivity and inflammation including sputum eosinophilia and eosinophilic cationic protein, fraction of expired nitric oxide, and urinary leukotriene.
Time frame: 6 weeks
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 8 Jun 2011.
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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.
Ravi Kalhan, MD, MS 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 Isoflavone 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 4 inclusion and 7 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 8 Jun 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?
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?
Change in airway reactivity induced by dietary supplementation with soy isoflavones. Airway reactivity will be measured with methacholine bronchoprovocation testing. (time frame: 6 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 8 Jun 2011; AzTrials last refreshed its copy on 6 Nov 2026.