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History of Changes for Study: NCT01522703
Effects of Whole Sprouts on Upper Airway Allergic Inflammation
Latest version (submitted November 24, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 27, 2012 None (earliest Version on record)
2 September 19, 2013 Recruitment Status, Study Status, Contacts/Locations, Study Description and Oversight
3 September 12, 2014 Study Status and Contacts/Locations
4 September 5, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 November 24, 2016 Study Status, Outcome Measures, Study Identification, Results, Eligibility, Study Design and Study Description
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Study NCT01522703
Submitted Date:  January 27, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: NA_00067371
Brief Title: Effects of Whole Sprouts on Upper Airway Allergic Inflammation
Official Title: Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Upper Airway Allergic Inflammation
Secondary IDs: 1P01ES018176-01 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: January 2012
Overall Status: Not yet recruiting
Study Start: March 2012
Primary Completion: March 2014 [Anticipated]
Study Completion: March 2014 [Anticipated]
First Submitted: January 9, 2012
First Submitted that
Met QC Criteria:
January 27, 2012
First Posted: February 1, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 27, 2012
Last Update Posted: February 1, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Johns Hopkins University
Responsible Party: Principal Investigator
Investigator: Elizabeth Matsui
Official Title: Associate Professor
Affiliation: Johns Hopkins University
Collaborators: National Institute of Environmental Health Sciences (NIEHS)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

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.

Detailed Description:
Open or close this module Conditions
Conditions: Allergic Rhinitis
Asthma
Allergy
Keywords: asthma
allergic rhinitis
dietary interventions
mouse allergy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 24 [Anticipated]
Open or close this module Arms and Interventions
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 Names:
  • 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 Names:
  • sprouts, alfalfa, broccoli sprouts
Open or close this module Outcome Measures
Primary Outcome Measures:
1. IL6 levels
[ Time Frame: at 3 days ]

Change in nasal lavage IL-6 levels following NAC
Secondary Outcome Measures:
1. biomarkers of inflammation in nasal epithelial cells
[ Time Frame: at 3 days ]

- In nasal epithelial cells: phase II enzyme gene expression
2. Respiratory Symptoms
[ Time Frame: at 3 days ]

airway symptoms
3. nasal lavage
[ Time Frame: at 3 days ]

nasal lavage inflammatory mediators
4. biomarkers of inflammation in blood
[ Time Frame: at 3 days ]

markers of inflammation in blood samples
5. biomarkers of inflammation in urine
[ Time Frame: at 3 days ]

inflammation markers measured from urine samples
6. biomarkers of oxidative stress
[ Time Frame: at 3 days ]

markers of oxidative stress measured from urine samples
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Mary Jane Ong
Telephone: 410-502-9263
Email: mong1@jhmi.edu
Study Officials: Elizabeth Matsui, MD, MHS
Principal Investigator
Johns Hopkins University
Locations: United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21202
Contact:Contact: Mary Jane Ong 410-502-9263 mong1@jhmi.edu
Contact:Principal Investigator: Elizabeth Matsui, MD, MHS
Contact:Sub-Investigator: Meredith McCormack, MD, MHS
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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