Clinical trial NCT02885025: Effects of Broccoli Sprout Extract on Allergy Rhinitis
Official title: Effects of Broccoli Sprout Extract on Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis,Allergic
Keywords: hypersensitivity
antioxidants
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-08-31
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

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.

Primary outcomes:
measure: Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
timeFrame: measures at various points following challenge at baseline and 21 days
measure: Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
timeFrame: 21 days (from randomization to completion)
Secondary outcomes:
measure: Interleukin 5 (IL5)
timeFrame: 21 days (from randomization to completion)
measure: Interleukin 4 (IL4)
timeFrame: 21 days (from randomization to completion)
measure: Interleukin 6 (IL6)
timeFrame: 21 days (from randomization to completion)
measure: Interleukin 8 (IL8)
timeFrame: 21 days (from randomization to completion)
measure: Interleukin 13 (IL13)
timeFrame: 21 days (from randomization to completion)
measure: Interleukin 1 Beta (IL1b)
timeFrame: 21 days (from randomization to completion)
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Zhaoping Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Joseph Stephen Yusin, MD
role: PRINCIPAL_INVESTIGATOR
References: