Effects of Broccoli Sprout Extract on Allergy Rhinitis

VA Office of Research and Development

Status and phase

Completed

Phase 2

Conditions

Rhinitis,Allergic

Treatments

Dietary Supplement: Broccoli Sprout Extract

Dietary Supplement: broccoli sprout extract placebo

Drug: fluticasone nasal

Drug: normal saline nasal spray

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02885025

CLNB-03-15F

Details and patient eligibility

About

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.

Full description

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Inclusion Criteria

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

Exclusion criteria

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.
History of anaphylaxis to environmental allergens or an unknown trigger.
History of broccoli allergy
Recent upper respiratory infection (less than 4 weeks prior to study) or other active Infection.
Active smoker
Currently receiving allergy immunotherapy.
History of rhinitis exacerbation within the past 2 weeks.
Use of non-selective Beta-Blocker.
Inability to give written informed consent.
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.
Pregnancy
Perennial rhinitis
Uncontrolled asthma
Forced Expiratory Volume in 1 second <70% predicted at screening.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

47 participants in 4 patient groups, including a placebo group

BSE + Nasal Fluticasone

Active Comparator group

Description:

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

Treatment:

Drug: fluticasone nasal

Dietary Supplement: Broccoli Sprout Extract

Broccoli Sprout Extract + normal saline nasal spray

Active Comparator group

Description:

Treatment:

Drug: normal saline nasal spray

Dietary Supplement: Broccoli Sprout Extract

Placebo Pill + Nasal Fluticasone

Active Comparator group

Description:

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

Treatment:

Drug: fluticasone nasal

Dietary Supplement: broccoli sprout extract placebo

Placebo Pill + normal saline nasal spray

Placebo Comparator group

Description:

Treatment:

Drug: normal saline nasal spray

Dietary Supplement: broccoli sprout extract placebo

Trial documents