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Effects of Whole Sprouts on Upper Airway Allergic Inflammation

This study is not yet open for participant recruitment.
Verified January 2012 by Johns Hopkins University
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Elizabeth Matsui, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01522703
First received: January 9, 2012
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

The primary objective of this study is to determine if broccoli sprouts (BS) improves nasal inflammatory, oxidative stress (OS), and symptom responses to nasal mouse allergen challenge (NAC) in mouse-sensitized adults with asthma or perennial allergic rhinitis.

The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 24 mouse-sensitized adults with asthma or perennial rhinitis and who develop rhinitis symptoms with nasal mouse allergen challenge. Twenty-four adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo. At the baseline NAC, FENO, FEV1, nasal epithelial gene expression, urinary OS biomarkers, serum inflammatory and OS biomarkers, basophil activation, and symptoms will be assessed both before and after NAC to establish pre-intervention responses to NAC. Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat NAC that includes measurement of the above outcomes both before and after NAC.


Condition Intervention
Allergic Rhinitis
Asthma
Allergy
 Drug: Broccoli Sprouts
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Upper Airway Allergic Inflammation

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • IL6 levels [ Time Frame: at 3 days ] [ Designated as safety issue: No ]
    Change in nasal lavage IL-6 levels following NAC


Secondary Outcome Measures:
  • biomarkers of inflammation in nasal epithelial cells [ Time Frame: at 3 days ] [ Designated as safety issue: No ]
    - In nasal epithelial cells: phase II enzyme gene expression

  • Respiratory Symptoms [ Time Frame: at 3 days ] [ Designated as safety issue: No ]
    airway symptoms

  • nasal lavage [ Time Frame: at 3 days ] [ Designated as safety issue: No ]
    nasal lavage inflammatory mediators

  • biomarkers of inflammation in blood [ Time Frame: at 3 days ] [ Designated as safety issue: No ]
    markers of inflammation in blood samples

  • biomarkers of inflammation in urine [ Time Frame: at 3 days ] [ Designated as safety issue: No ]
    inflammation markers measured from urine samples

  • biomarkers of oxidative stress [ Time Frame: at 3 days ] [ Designated as safety issue: No ]
    markers of oxidative stress measured from urine samples


Estimated Enrollment: 24
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Broccoli Sprouts
Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days
 Drug: Broccoli Sprouts
100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.
Other Name: sprouts, broccoli sprouts
Placebo Comparator: Alfalfa Sprouts
Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days
 Drug: Placebo
Alfalfa Sprouts
Other Name: sprouts, alfalfa, broccoli sprouts

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Perennial rhinitis or doctor diagnosis of asthma
  • Positive mouse skin test or specific IgE
  • Non-smoker
  • Negative pregnancy test
  • Not breastfeeding
  • Normal TSH
  • For women, abstinent or using reliable birth control
  • Age 18-50 years
  • No other major pulmonary disease such as cystic fibrosis or COPD
  • Willingness to participate in study and sign consent form

Exclusion Criteria:

  • Severe or unstable asthma defined as requiring hospitalization in the previous 6 months or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
  • Uncontrolled asthma defined as short-acting beta agonist use 3 or more days a week in the previous 4 weeks
  • A history of anaphylaxis or hospitalization due to mouse exposure
  • FEV1 <80% predicted
  • Other significant medical issues such as heart disease or poorly controlled hypertension, type 1 diabetes, poorly controlled type 2 diabetes, or hypothyroidism
  • Pregnancy or nursing/breastfeeding mothers
  • On beta-blocker therapy
  • On reserpine, clonidine, imipramine, or related tricyclic drugs
  • Taking anti-oxidant supplements
  • Planned dietary changes during the study period
  • Unable to stop antihistamines prior to skin testing
  • Unable to stop medications that may interfere with nasal challenge responses prior to challenges
  • Food allergy to Broccoli Sprouts or Alfalfa Sprouts
  • Omalizumab use within the last 12 months
  • Nasal polyps
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522703

Contacts
Contact: Mary Jane Ong 410-502-9263 mong1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21202
Contact: Mary Jane Ong     410-502-9263     mong1@jhmi.edu    
Principal Investigator: Elizabeth Matsui, MD, MHS            
Sub-Investigator: Meredith McCormack, MD, MHS            
Sponsors and Collaborators
Johns Hopkins University
National Institute of Environmental Health Sciences (NIEHS)
Investigators
Principal Investigator: Elizabeth Matsui, MD, MHS Johns Hopkins University
  More Information

No publications provided

Responsible Party: Elizabeth Matsui, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01522703     History of Changes
Other Study ID Numbers: NA_00067371, 1P01ES018176-01
Study First Received: January 9, 2012
Last Updated: January 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
asthma
allergic rhinitis
dietary interventions
mouse allergy

Additional relevant MeSH terms:
Hypersensitivity
Asthma
Inflammation
Rhinitis
Immune System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Pathologic Processes
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013