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Effects of Whole Sprouts on Airway Allergic Inflammation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522703
First Posted: February 1, 2012
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Elizabeth Matsui, Johns Hopkins University
January 9, 2012
February 1, 2012
August 8, 2016
January 19, 2017
January 19, 2017
March 2012
March 2015   (Final data collection date for primary outcome measure)
Exhaled Nitric Oxide Concentrations [ Time Frame: at 3 days ]
exhaled nitric oxide concentrations
IL6 levels [ Time Frame: at 3 days ]
Change in nasal lavage IL-6 levels following NAC
Complete list of historical versions of study NCT01522703 on ClinicalTrials.gov Archive Site
Not Provided
  • 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
Not Provided
Not Provided
 
Effects of Whole Sprouts on Airway Allergic Inflammation
Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Airway Allergic Inflammation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Allergic Rhinitis
  • Asthma
  • Allergy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
March 2015
March 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01522703
NA_00067371
1P01ES018176-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Elizabeth Matsui, Johns Hopkins University
Johns Hopkins University
National Institute of Environmental Health Sciences (NIEHS)
Principal Investigator: Elizabeth Matsui, MD, MHS Johns Hopkins University
Johns Hopkins University
October 2016

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