Status:

COMPLETED

Dietary Supplementation With Soy Isoflavones in Asthma

Lead Sponsor:

Northwestern University

Conditions:

Asthma

Eligibility:

All Genders

18-50 years

Phase:

NA

Brief Summary

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 geniste...

Detailed Description

This is a prospective pilot study to be conducted in 20 subjects with asthma. The participant will undergo the following procedures: 1. Completion of a questionnaire that asks for information about a...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2007

Estimated Enrollment :

13 Patients enrolled

Trial Details

Trial ID

NCT00277446

Start Date

January 1 2006

End Date

April 1 2007

Last Update

February 25 2011

Active Locations (1)

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1

Northwestern University

Chicago, Illinois, United States, 60611