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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.
This is a prospective pilot study to be conducted in 20 subjects with asthma. The participant will undergo the following procedures:
Each of the above measurements will be made before and after the 4 week period of dietary supplementation with soy isoflavones.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soy isoflavones | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled Nitric Oxide | Exhaled nitric oxide at baseline (week 0) and at 4 weeks | 0 and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 and 4 weeks |
| Forced Expiratory Volume in One Second (FEV1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lewis J Smith, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
Patients with asthma were included in the study if they had mild-to-moderate disease not fully controlled on their current treatment.
Patients with asthma were recruited from Northwestern's medical clinics and by advertisements in the community.
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| ID | Title | Description |
|---|---|---|
| FG000 | Soy Isoflavone Supplement | This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Soy Isoflavone Supplement | This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exhaled Nitric Oxide | Exhaled nitric oxide at baseline (week 0) and at 4 weeks | Per protocol | Posted | Mean | Standard Deviation | parts per billion (ppb) | 0 and 4 weeks |
|
|
Duration of study = 4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Soy Isoflavone Supplement | This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lewis J. Smith | Northwestern University | 312-503-0501 | ljsmith@northwestern.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
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Forced expiratory volume in one second (FEV1) measured as liters/second |
| 0 and 4 weeks |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/ml | 0 and 4 weeks |
|
|
|
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) | Forced expiratory volume in one second (FEV1) measured as liters/second | Posted | Mean | Standard Deviation | liters/sec | 0 and 4 weeks |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004044 |
| Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |