Dietary Supplementation With Soy Isoflavones in Asthma
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|ClinicalTrials.gov Identifier: NCT00277446|
Recruitment Status : Completed
First Posted : January 16, 2006
Results First Posted : February 24, 2011
Last Update Posted : February 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Soy isoflavones||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dietary Supplementation With Soy Isoflavones in Asthma|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
- Exhaled Nitric Oxide [ Time Frame: 0 and 4 weeks ]Exhaled nitric oxide at baseline (week 0) and at 4 weeks
- Eosinophil LTC4 Synthesis [ Time Frame: 0 and 4 weeks ]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.
- Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 0 and 4 weeks ]Forced expiratory volume in one second (FEV1) measured as liters/second
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277446
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Lewis J Smith, MD||Northwestern University|