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临床试验/NCT00994604
NCT00994604已完成不适用

The Effects of Broccoli Sprout Extract on Obstructive Lung Disease

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract

研究概览

简要总结

The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.

详细描述

Asthma afflicts 23 million people, results in nearly 13 million ambulatory physician encounters, and 440,000 hospitalizations annually. The economic burden for 2010 is estimated to run $20.7 billion.

Although steroids are the mainstay of treatment, they do not "cure" the disease. While inflammation may be the inciting factor, other mechanisms must play a crucial role in this process. Elevated oxidative stress could cause the kind of chronic inflammation associated with asthma, and could provide an explanation for recurrent asthma attacks. Cigarette smoke, both primary and secondary exposure, worsens the oxidative stress balance in the airways. Thus, the continuing focus on simply treating the inflammation is a barrier to progress. It is critical to examine other factors, such as abnormal oxidative stress through specific pathways that may affect airway inflammation and asthma attacks.

One compound, that repairs oxidative stress pathways, is sulforaphane, a food compound found in vegetables, including broccoli sprouts. Preliminary data demonstrate that broccoli sprout extract (BSE), rich in sulforaphane, improves airflow measures in asthmatics.

We plan to examine whether the airflow abnormalities in asthma, and the exacerbation from cigarette smoke, can be prevented by the administration of BSE, and determine the primary inflammatory and oxidative stress signaling pathways involved in the protection provided by BSE.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • currently on chronic oral steroid medications
  • current respiratory symptoms
  • FEV1 less than 40% predicted at baseline
  • extreme degrees of bronchial hyperreactivity
  • recent respiratory infection (<3 weeks)
  • unstable symptoms in the prior month
  • a history of intubation for respiratory symptoms within the past year
  • any history of cardiac disease.

研究组 & 干预措施

broccoli sprout extract

Experimental

This a before and after treatment study. The subjects will consumer broccoli sprout extract (BSE) for two weeks (14d). Lung function and Chest CT will be performed before and after BSE consumption.

干预措施: broccoli sprout extract (Drug)

结局指标

主要结局

The Primary Outcome is the Change in Bronchodilation and Bronchoprotection After Broccoli Sprout Extract

时间窗: baseline and two weeks

Bronchodilator index = (1- ((1 - ((forced expiratory volume in 1 second after Methacholine A and after Deep Inspiration )÷( forced expiratory volume in 1 second baseline)))÷ (1 - ((forced expiratory volume in 1 second after Methacholine)÷( forced expiratory volume in 1 second baseline)))))x100 Bronchoprotection index = (1- ((1 - ((forced expiratory volume in 1 second after Deep Inspirations and after Methacholine B )÷( forced expiratory volume in 1 second baseline B)))÷(1 - ((forced expiratory volume in 1 second after Methacholine A)÷( forced expiratory volume in 1 second baseline A))))) x 100

次要结局

  • Changes in Airway Size by Computed Tomography(baseline and after two weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Brown

Professor

Johns Hopkins University

研究点 (1)

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