NCT02885025

Effects of Broccoli Sprout Extract on Allergy Rhinitis

Effects of Broccoli Sprout Extract on Allergic Rhinitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Rhinitis,Allergic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Broccoli Sprout Extract	Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
DRUG	fluticasone nasal	fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
DIETARY_SUPPLEMENT	broccoli sprout extract placebo	a tablet similar to the actual broccoli sprout extract though without BSE.
DRUG	normal saline nasal spray	normal saline to replace nasal fluticasone in specific arms of the study

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-03-12
• Completion: 2019-03-12
• First posted: 2016-08-31
• Last updated: 2020-06-19
• Results posted: 2020-06-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study