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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:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Elizabeth Matsui, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE January 9, 2012
First Posted Date  ICMJE February 1, 2012
Results First Submitted Date  ICMJE August 8, 2016
Results First Posted Date  ICMJE January 19, 2017
Last Update Posted Date January 19, 2017
Study Start Date  ICMJE March 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2016)
Exhaled Nitric Oxide Concentrations [ Time Frame: at 3 days ]
exhaled nitric oxide concentrations
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2012)
IL6 levels [ Time Frame: at 3 days ]
Change in nasal lavage IL-6 levels following NAC
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2012)
  • biomarkers of inflammation in nasal epithelial cells [ Time Frame: at 3 days ]
    - In nasal epithelial cells: phase II enzyme gene expression
  • Respiratory Symptoms [ Time Frame: at 3 days ]
    airway symptoms
  • nasal lavage [ Time Frame: at 3 days ]
    nasal lavage inflammatory mediators
  • biomarkers of inflammation in blood [ Time Frame: at 3 days ]
    markers of inflammation in blood samples
  • biomarkers of inflammation in urine [ Time Frame: at 3 days ]
    inflammation markers measured from urine samples
  • biomarkers of oxidative stress [ Time Frame: at 3 days ]
    markers of oxidative stress measured from urine samples
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Whole Sprouts on Airway Allergic Inflammation
Official Title  ICMJE Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Allergic Rhinitis
  • Asthma
  • Allergy
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Alfalfa Sprouts
    Other Name: sprouts, alfalfa, broccoli sprouts
Study Arms  ICMJE
  • Experimental: Broccoli Sprouts
    Broccoli Sprout sandwich/wrap will be eaten daily for 3 consecutive days
    Intervention: Drug: Broccoli Sprouts
  • Placebo Comparator: Alfalfa Sprouts
    Alfalfa Sprouts will be eaten daily in a sandwich form for 3 consecutive days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2016)
51
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2012)
24
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01522703
Other Study ID Numbers  ICMJE NA_00067371
1P01ES018176-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Matsui, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute of Environmental Health Sciences (NIEHS)
Investigators  ICMJE
Principal Investigator: Elizabeth Matsui, MD, MHS Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP