- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00277446
Dietary Supplementation With Soy Isoflavones in Asthma
February 23, 2011 updated by: Northwestern University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exhaled Nitric Oxide
Time Frame: 0 and 4 weeks
|
Exhaled nitric oxide at baseline (week 0) and at 4 weeks
|
0 and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0 and 4 weeks
|
Forced Expiratory Volume in One Second (FEV1)
Time Frame: 0 and 4 weeks
|
Forced expiratory volume in one second (FEV1) measured as liters/second
|
0 and 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lewis J Smith, MD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
January 13, 2006
First Submitted That Met QC Criteria
January 13, 2006
First Posted (Estimate)
January 16, 2006
Study Record Updates
Last Update Posted (Estimate)
February 25, 2011
Last Update Submitted That Met QC Criteria
February 23, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0456-035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on Soy isoflavones
-
Baylor College of MedicineUniversity of Alabama at Birmingham; Texas A&M University; University of Georgia and other collaboratorsCompletedOsteoporosisUnited States
-
Ohio State UniversityCompleted
-
University of Massachusetts, BostonTufts University; University of Massachusetts, Worcester; Hallmark Health SystemCompleted
-
University of Hawaii Cancer Research CenterNational Cancer Institute (NCI)CompletedBreast Cancer | Healthy, no Evidence of DiseaseUnited States
-
National Center for Complementary and Integrative...Completed
-
Thomas Jefferson UniversityJohnson & JohnsonCompletedMigraine HeadacheUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedProstate CancerUnited States
-
Children's Hospital Medical Center, CincinnatiNational Cancer Institute (NCI)UnknownUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Brigham and Women's HospitalCompleted
-
The Archer-Daniels-Midland CompanyEurofins Dermscan PharmascanCompleted