Effects of Whole Sprouts on Upper Airway Allergic Inflammation

Asthma Clinical Trial

Official title:

Dietary Interventions and Asthma Treatment: A Pilot Study of the Effects of Whole Sprouts on Upper Airway Allergic Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01522703
• Other study ID #: NA_00067371
• Secondary ID: 1P01ES018176-01
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: September 5, 2015
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine if broccoli sprouts (BS) improves nasal inflammatory, oxidative stress (OS), and symptom responses to nasal mouse allergen challenge (NAC) in mouse-sensitized adults perennial allergic rhinitis.

The study is a double-blind, placebo-controlled, randomized trial to compare BS to placebo in 24 mouse-sensitized adults with asthma or perennial rhinitis and who develop rhinitis symptoms with nasal mouse allergen challenge. Twenty-four adults (age 18-50) who meet these eligibility criteria will be randomized to receive either: (a) BS or (b) placebo. At the baseline NAC, FENO, FEV1, nasal epithelial gene expression, urinary OS biomarkers, serum inflammatory and OS biomarkers, basophil activation, and symptoms will be assessed both before and after NAC to establish pre-intervention responses to NAC. Subjects will eat a sprouts sandwich daily for three days, and then undergo repeat NAC that includes measurement of the above outcomes both before and after NAC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Perennial rhinitis or doctor diagnosis of asthma

• Positive mouse skin test or specific IgE

• 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

• A history of anaphylaxis or hospitalization due to mouse exposure

• FEV1 <80% predicted

• 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

• Unable to stop medications that may interfere with nasal challenge responses prior to challenges

• Food allergy to Broccoli Sprouts or Alfalfa Sprouts

• Omalizumab use within the last 12 months

• Nasal polyps

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergy
• Asthma

Intervention

Drug:
• Broccoli Sprouts
100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.
• Placebo
Alfalfa Sprouts

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IL6 levels	Change in nasal lavage IL-6 levels following NAC	at 3 days	No
Secondary	biomarkers of inflammation in nasal epithelial cells	- In nasal epithelial cells: phase II enzyme gene expression	at 3 days	No
Secondary	Respiratory Symptoms	airway symptoms	at 3 days	No
Secondary	nasal lavage	nasal lavage inflammatory mediators	at 3 days	No
Secondary	biomarkers of inflammation in blood	markers of inflammation in blood samples	at 3 days	No
Secondary	biomarkers of inflammation in urine	inflammation markers measured from urine samples	at 3 days	No
Secondary	biomarkers of oxidative stress	markers of oxidative stress measured from urine samples	at 3 days	No