Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT00741208
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2008-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modification of Asthma With Soy Isoflavone
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Modification of Asthma With Soy Isoflavone
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: