NCT01522703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 19, 2017

Completed
Last Updated

January 19, 2017

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

January 9, 2012

Results QC Date

August 8, 2016

Last Update Submit

November 24, 2016

Conditions

Allergic RhinitisAsthmaAllergy

Keywords

asthmaallergic rhinitisdietary interventionsmouse allergy

Outcome Measures

Primary Outcomes (1)

  • Exhaled Nitric Oxide Concentrations

    exhaled nitric oxide concentrations

    at 3 days

Study Arms (2)

Broccoli Sprouts

EXPERIMENTAL

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

Drug: Broccoli Sprouts

Alfalfa Sprouts

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Broccoli SproutsDRUG

100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.

Also known as: sprouts, broccoli sprouts
Broccoli Sprouts
PlaceboDRUG

Alfalfa Sprouts

Also known as: sprouts, alfalfa, broccoli sprouts
Alfalfa Sprouts

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Rhinitis, AllergicAsthmaHypersensitivity

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System DiseasesBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Results Point of Contact

Title
Elizabeth Matsui, MD MHS
Organization
Johns Hopkins University School of Medicine
ematsui@jhmi.edu
410-502-3858

Study Officials

  • Elizabeth Matsui, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 9, 2012

First Posted

February 1, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

January 19, 2017

Results First Posted

January 19, 2017

Record last verified: 2016-10

Locations

US(1)