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Effects of Whole Sprouts on Airway Allergic Inflammation

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ClinicalTrials.gov Identifier: NCT01522703
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Allergic Rhinitis Asthma Allergy Drug: Broccoli Sprouts Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation
Study Start Date : March 2012
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Exhaled Nitric Oxide Concentrations [ Time Frame: at 3 days ]
    exhaled nitric oxide concentrations


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522703


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21202
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

Responsible Party: Elizabeth Matsui, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01522703     History of Changes
Other Study ID Numbers: NA_00067371
1P01ES018176-01 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2012    Key Record Dates
Results First Posted: January 19, 2017
Last Update Posted: January 19, 2017
Last Verified: October 2016

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

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