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NCT00277446 · ClinicalTrials.gov registry record · NA

Dietary Supplementation With Soy Isoflavones in Asthma

A NA study, sponsored by Northwestern University.

Completed
Registry status
NA
Development phase
13
Enrollment target

NCT00277446: Completed NA study, sponsored by Northwestern University.

NCT00277446 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00277446, a NA study, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
NA
Development phase
13 participants
Enrollment target

Study 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 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.

Primary Outcome

Exhaled nitric oxide at baseline (week 0) and at 4 weeks

Interventions

  • DRUG Soy isoflavones

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2006-01
Est. Completion 2007-04
Phase NA
Northwestern University

1,209 total trials

What the finished NCT00277446 record still lists

NCT00277446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Soy isoflavones is the first listed.

NCT00277446 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00277446 about?

NCT00277446 is a clinical study titled "Dietary Supplementation With Soy Isoflavones in Asthma". 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 show...

What is the current status of trial NCT00277446?

This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2006-01. Estimated completion is 2007-04.

What interventions are being tested in trial NCT00277446?

The interventions under investigation include: Soy isoflavones (DRUG).

Who is sponsoring clinical trial NCT00277446?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00277446's enrollment target sits among peer trials

13 1911th of 2000 higher than 88 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00277446, the US trial registry maintained by the National Library of Medicine. NCT00277446 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.