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Effects of Whole Sprouts on Airway Allergic Inflammation

Primary Purpose

Allergic Rhinitis, Asthma, Allergy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Broccoli Sprouts
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring asthma, allergic rhinitis, dietary interventions, mouse allergy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • doctor diagnosis of asthma
  • aeroallergen sensitization
  • 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
  • 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
  • Food allergy to Broccoli Sprouts or Alfalfa Sprouts
  • Omalizumab use within the last 12 months
  • Nasal polyps

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Broccoli Sprouts

Alfalfa Sprouts

Arm Description

Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days

Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days

Outcomes

Primary Outcome Measures

Exhaled Nitric Oxide Concentrations
exhaled nitric oxide concentrations

Secondary Outcome Measures

Full Information

First Posted
January 9, 2012
Last Updated
November 24, 2016
Sponsor
Johns Hopkins University
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
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1. Study Identification

Unique Protocol Identification Number
NCT01522703
Brief Title
Effects of Whole Sprouts on Airway Allergic Inflammation
Official Title
Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to determine if broccoli sprouts (BS) improves airway inflammatory, oxidative stress (OS), and symptoms among asthmatic adults with aeroallergen sensitization. The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 40 adults with asthma. 40 adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo (alfalfa sprouts). Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat measurement of outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Asthma, Allergy
Keywords
asthma, allergic rhinitis, dietary interventions, mouse allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Broccoli Sprouts
Arm Type
Experimental
Arm Description
Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days
Arm Title
Alfalfa Sprouts
Arm Type
Placebo Comparator
Arm Description
Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Broccoli Sprouts
Other Intervention Name(s)
sprouts, broccoli sprouts
Intervention Description
100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sprouts, alfalfa, broccoli sprouts
Intervention Description
Alfalfa Sprouts
Primary Outcome Measure Information:
Title
Exhaled Nitric Oxide Concentrations
Description
exhaled nitric oxide concentrations
Time Frame
at 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: doctor diagnosis of asthma aeroallergen sensitization 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 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 Food allergy to Broccoli Sprouts or Alfalfa Sprouts Omalizumab use within the last 12 months Nasal polyps
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Matsui, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States

12. IPD Sharing Statement

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Effects of Whole Sprouts on Airway Allergic Inflammation

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