Effects of Broccoli Sprout Extract on Allergy Rhinitis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2019-03-12

Brief Summary

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Allergic rhinitis is a common illness suffered among US Veterans. There are medications that help relieve allergy symptoms, including nasal steroid sprays and antihistamines. Some patients have increase symptoms with exposure to their trigger, such as a grasses when combined with pollution due to oxidative stress from pollution. In this study, patients with allergic rhinitis to grass will be given broccoli sprout extract that contains an antioxidant sulforaphane do see if there is beneficial effect in these patients.

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Detailed Description

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Allergic rhinitis is a common illness suffered among US Veterans. Despite the availability of medications, many patients fail to get adequate control of symptoms especially in high pollutant areas. Southern California air pollutants, like diesel exhaust particles may act as adjuvants to allergens leading to an exaggerated allergic response in certain individuals. These individuals may lack adequate Glutathione transferase activity; necessary to protect cells against pollutant induced oxidative stress. Sulforaphane has been shown to protect against oxidative stress. The investigators hypothesize consumption of foods containing high levels of sulforaphane are beneficial to US Veterans with GST deficiencies suffering from allergic rhinitis. In the investigators' preliminary data, the investigators discovered administration of broccoli sprout extract rich in sulforaphane leads to diminished nasal inflammatory reaction brought on by diesel exhaust particles though did not have sufficient patient numbers to prove an association with GST deficiency. The investigators propose a 3 week randomized clinical trial comparing broccoli sprout extract consumption with nasal corticosteroid administration after subjects with allergic rhinitis undergo a Timothy, Bermuda or Johnson grass nasal challenge. In Aims 1 and 2, the investigators will compare clinical (nasal symptom scores and peak nasal inspiratory flows) and laboratory (inflammatory cytokines, eosinophil cationic protein, tryptase) measurements between four groups: nasal corticosteroid, broccoli sprout extract, nasal corticosteroid plus broccoli sprout extract, and placebo. Aim 3 focuses on exploratory genetic analysis of the 3 glutathione S-transferase (GST) genes to determine if correlations exist between the inability to produce GST enzyme and the response to broccoli sprout extract. At the conclusion of this study, the investigators will gain further knowledge of which patients benefit from anti-oxidant nutritional supplementation in treating allergic rhinitis.

Conditions

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Rhinitis,Allergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BSE + Nasal Fluticasone

subjects will be randomized into 1 of 4 arms:

1. Broccoli Sprout Extract + Nasal Fluticasone
2. Broccoli Sprout Extract + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray

Group Type ACTIVE_COMPARATOR

Broccoli Sprout Extract

Intervention Type DIETARY_SUPPLEMENT

Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.

fluticasone nasal

Intervention Type DRUG

fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.

Broccoli Sprout Extract + normal saline nasal spray

subjects will be randomized into 1 of 4 arms:

1. Broccoli Sprout Extract + Nasal Fluticasone
2. Broccoli Sprout Extract + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray

Group Type ACTIVE_COMPARATOR

Broccoli Sprout Extract

Intervention Type DIETARY_SUPPLEMENT

Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.

normal saline nasal spray

Intervention Type DRUG

normal saline to replace nasal fluticasone in specific arms of the study

Placebo Pill + Nasal Fluticasone

subjects will be randomized into 1 of 4 arms:

1\. Broccoli Sprout Extract + Nasal Fluticasone 2 Broccoli Sprout Extract + normal saline nasal spray 3. Placebo Pill + Nasal Fluticasone 4. Placebo Pill + normal saline nasal spray

Group Type ACTIVE_COMPARATOR

fluticasone nasal

Intervention Type DRUG

fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.

broccoli sprout extract placebo

Intervention Type DIETARY_SUPPLEMENT

a tablet similar to the actual broccoli sprout extract though without BSE.

Placebo Pill + normal saline nasal spray

subjects will be randomized into 1 of 4 arms:

1. Broccoli Sprout Extract + Nasal Fluticasone
2. Broccoli Sprout Extract + normal saline nasal spray
3. Placebo Pill + Nasal Fluticasone
4. Placebo Pill + normal saline nasal spray

Group Type PLACEBO_COMPARATOR

broccoli sprout extract placebo

Intervention Type DIETARY_SUPPLEMENT

a tablet similar to the actual broccoli sprout extract though without BSE.

normal saline nasal spray

Intervention Type DRUG

normal saline to replace nasal fluticasone in specific arms of the study

Interventions

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Broccoli Sprout Extract

Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.

Intervention Type DIETARY_SUPPLEMENT

fluticasone nasal

fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.

Intervention Type DRUG

broccoli sprout extract placebo

a tablet similar to the actual broccoli sprout extract though without BSE.

Intervention Type DIETARY_SUPPLEMENT

normal saline nasal spray

normal saline to replace nasal fluticasone in specific arms of the study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Females and males 18 years or older.
2. History consistent with seasonal allergic rhinitis consistent with grass allergy (symptoms during summer months, June through August, for at least two consecutive seasons).
3. Not currently taking any medications for allergic rhinitis.
4. Provide written informed consent.
5. Willing and able to comply with all aspects of the protocol.

Exclusion Criteria

1. The subject has any uncontrolled or serious disease, or any medical or surgical or condition that in the opinion of the investigator(s) could affect the subject's safety and/or interfere with the study assessments.
2. History of anaphylaxis to environmental allergens or an unknown trigger.
3. History of broccoli allergy
4. Recent upper respiratory infection (less than 4 weeks prior to study) or other active Infection.
5. Active smoker
6. Currently receiving allergy immunotherapy.
7. History of rhinitis exacerbation within the past 2 weeks.
8. Use of non-selective Beta-Blocker.
9. Inability to give written informed consent.
10. History or evidence of non-stable cognitive capacity within less than 1 year (i.e. Alzheimer's disease, dementia, bipolar disorder) that in the opinion of the investigator(s) could affect the subject's safety and/or interfere with the study assessments.
11. Pregnancy
12. Perennial rhinitis
13. Uncontrolled asthma
14. Forced Expiratory Volume in 1 second \<70% predicted at screening.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes