Dietary Interventions in Asthma Treatment: Sprouts Study

NCT ID: NCT01183923

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-02-06

Brief Summary

Sulforaphane (SFN) is a naturally occurring isothiocyanate that is a potent inducer of Phase II enzymes which play a critical role in preventing oxidative stress (via activation of Nrf2). Broccoli sprouts (BS) contain the richest source of SFN.

The main objectives of this study are to test the effect of broccoli sprouts (BS) on biomarkers of oxidative stress (OS), inflammation, basophil activation, and clinical outcomes in mouse allergen-induced asthma by (1) determining if BS improves lung function and airways symptom responses in mouse-sensitized adults with asthma undergoing environmental mouse allergen challenge (EMAC), (2) examining the effect of BS on OS, inflammation, and basophil activation, and (3) examining the effect of BS on changes in OS, inflammation, and basophil activation after EMAC.

Detailed Description

After eligibility is confirmed, participants will be randomized to (a) placebo then BS or (b) BS then placebo. At randomization, baseline exhaled nitric oxide (eNO), forced expiratory volume at one second (FEV1), nasal epithelial gene expression, urinary OS biomarkers, serum inflammatory and OS biomarkers, and basophil activation will be assessed. These will be assessed again after 7 days on the assigned intervention at two time points: pre- and post-EMAC. The 1 week time period was chosen because previous studies have shown that daily ingestion of a broccoli sprout homogenate for three days resulted in upregulation of phase II enzyme gene expression in nasal epithelial cells. Following a 2-week washout period, this protocol will be repeated for the second intervention, phase II. The 2 week washout period will be sufficient as the half life of the extract of the active ingredient in broccoli sprouts, SFN, has been shown to be 1.8 hours.(16) Participants' diets will be assessed before and after each intervention with a Food Frequency Questionnaire and a questionnaire to capture intake of specific foods that are rich in SFN.

Conditions

Asthma; Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Broccoli Sprouts, then Alfalfa Sprouts

Broccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout.

Group Type: EXPERIMENTAL

Broccoli Sprouts

Intervention Type: OTHER

Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.

Alfalfa Sprouts

Intervention Type: OTHER

Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts.

Alfalfa Sprouts, then Broccoli Sprouts

Alfalfa Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by broccoli sprouts after washout.

Group Type: EXPERIMENTAL

Broccoli Sprouts

Intervention Type: OTHER

Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.

Alfalfa Sprouts

Intervention Type: OTHER

Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts.

Interventions

Broccoli Sprouts

Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.

Intervention Type: OTHER

Alfalfa Sprouts

Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18-49 years
• Physician-diagnosed asthma
• No other major pulmonary disease such as cystic fibrosis or chronic obstructive pulmonary disease (COPD)
• Mouse sensitization, defined by a positive skin prick test to mouse epithelial extract or positive mouse-specific immunoglobulin E (IgE)
• Non-smoker

Exclusion Criteria

• Severe or unstable asthma defined as requiring hospitalization in the previous year or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids
• Baseline FEV1 and FEV1/forced vital capacity (FVC) < 70% predicted
• Positive skin prick test (SPT) to a pet currently living in the participant's home
• Other significant medical issues such as heart disease or poorly controlled hypertension, or hypothyroidism
• Pregnancy or nursing/breastfeeding mothers
• On beta-blocker therapy
• Taking anti-oxidant supplements
• Unable to stop antihistamines prior to skin testing
• Unable to stop medications that may interfere with allergen challenge responses prior to challenges.
• The participant has food allergy to BS or AS.
• Omalizumab use within the last 12 months.
• Oral corticosteroid use within the last 2 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth C Matsui, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

References

Sudini K, Diette GB, Breysse PN, McCormack MC, Bull D, Biswal S, Zhai S, Brereton N, Peng RD, Matsui EC. A Randomized Controlled Trial of the Effect of Broccoli Sprouts on Antioxidant Gene Expression and Airway Inflammation in Asthmatics. J Allergy Clin Immunol Pract. 2016 Sep-Oct;4(5):932-40. doi: 10.1016/j.jaip.2016.03.012. Epub 2016 Apr 27.

Reference Type: DERIVED

PMID: 27130714 (View on PubMed)

Other Identifiers

1P01ES018176-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00035087

Identifier Type: -

Identifier Source: org_study_id