Effects of Whole Sprouts on Airway Allergic Inflammation

Johns Hopkins University

Status: Completed

Conditions: Asthma; Allergic Rhinitis; Allergy

Treatments: Drug: Placebo; Drug: Broccoli Sprouts

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01522703

1P01ES018176-01 (U.S. NIH Grant/Contract)

NA_00067371

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

Broccoli Sprouts

Experimental group

Description:

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

Treatment:

Drug: Broccoli Sprouts

Alfalfa Sprouts

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo