Dietary Interventions in Asthma Treatment: Sprouts Study

May 13, 2019 updated by: Johns Hopkins University

Sulforaphane (SFN) is a naturally occurring isothiocyanate that is a potent inducer of Phase II enzymes which play a critical role in preventing oxidative stress (via activation of Nrf2). Broccoli sprouts (BS) contain the richest source of SFN.

The main objectives of this study are to test the effect of broccoli sprouts (BS) on biomarkers of oxidative stress (OS), inflammation, basophil activation, and clinical outcomes in mouse allergen-induced asthma by (1) determining if BS improves lung function and airways symptom responses in mouse-sensitized adults with asthma undergoing environmental mouse allergen challenge (EMAC), (2) examining the effect of BS on OS, inflammation, and basophil activation, and (3) examining the effect of BS on changes in OS, inflammation, and basophil activation after EMAC.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

After eligibility is confirmed, participants will be randomized to (a) placebo then BS or (b) BS then placebo. At randomization, baseline exhaled nitric oxide (eNO), forced expiratory volume at one second (FEV1), nasal epithelial gene expression, urinary OS biomarkers, serum inflammatory and OS biomarkers, and basophil activation will be assessed. These will be assessed again after 7 days on the assigned intervention at two time points: pre- and post-EMAC. The 1 week time period was chosen because previous studies have shown that daily ingestion of a broccoli sprout homogenate for three days resulted in upregulation of phase II enzyme gene expression in nasal epithelial cells. Following a 2-week washout period, this protocol will be repeated for the second intervention, phase II. The 2 week washout period will be sufficient as the half life of the extract of the active ingredient in broccoli sprouts, SFN, has been shown to be 1.8 hours.(16) Participants' diets will be assessed before and after each intervention with a Food Frequency Questionnaire and a questionnaire to capture intake of specific foods that are rich in SFN.

Study Type

Interventional

Enrollment (Actual)

1

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

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins 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 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-49 years
  • Physician-diagnosed asthma
  • No other major pulmonary disease such as cystic fibrosis or chronic obstructive pulmonary disease (COPD)
  • Mouse sensitization, defined by a positive skin prick test to mouse epithelial extract or positive mouse-specific immunoglobulin E (IgE)
  • Non-smoker

Exclusion Criteria:

  • Severe or unstable asthma defined as requiring hospitalization in the previous year or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
  • Baseline FEV1 and FEV1/forced vital capacity (FVC) < 70% predicted
  • Positive skin prick test (SPT) to a pet currently living in the participant's home
  • Other significant medical issues such as heart disease or poorly controlled hypertension, or hypothyroidism
  • Pregnancy or nursing/breastfeeding mothers
  • On beta-blocker therapy
  • Taking anti-oxidant supplements
  • Unable to stop antihistamines prior to skin testing
  • Unable to stop medications that may interfere with allergen challenge responses prior to challenges.
  • The participant has food allergy to BS or AS.
  • Omalizumab use within the last 12 months.
  • Oral corticosteroid use within the last 2 weeks.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Broccoli Sprouts, then Alfalfa Sprouts
Broccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout.
Other: Broccoli Sprouts
Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.
Other: Alfalfa Sprouts
Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts.
Experimental: Alfalfa Sprouts, then Broccoli Sprouts
Alfalfa Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by broccoli sprouts after washout.
Other: Broccoli Sprouts
Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.
Other: Alfalfa Sprouts
Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Forced Expiratory Volume at One Second (FEV1)
Time Frame: 30 days
The percentage change in FEV1 from the pre-challenge FEV1 value over the 1 hour mouse chamber exposure.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Massachusetts General Hospital
National Institutes of Health (NIH)
National Institute of Environmental Health Sciences (NIEHS)

Investigators

  • Principal Investigator: Elizabeth C Matsui, MD MHS, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2010

Primary Completion (Actual)

February 6, 2012

Study Completion (Actual)

February 6, 2012

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

May 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00035087
  • 1P01ES018176-01 (U.S. NIH Grant/Contract)

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.

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