Effects of Whole Sprouts on Airway Allergic Inflammation

NCT ID: NCT01522703

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Allergic Rhinitis; Asthma; Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Broccoli Sprouts

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

Group Type: EXPERIMENTAL

Broccoli Sprouts

Intervention Type: DRUG

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

Alfalfa Sprouts

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Alfalfa Sprouts

Interventions

Broccoli Sprouts

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

Intervention Type: DRUG

Placebo

Alfalfa Sprouts

Intervention Type: DRUG

Other Intervention Names

sprouts, broccoli sprouts; sprouts, alfalfa, broccoli sprouts

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Matsui

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Matsui, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

1P01ES018176-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00067371

Identifier Type: -

Identifier Source: org_study_id