Effects of Broccoli Sprout Extract on Allergy Rhinitis



Status:Active, not recruiting
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:October 1, 2016
End Date:October 1, 2019

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Effects of Broccoli Sprout Extract on Allergic Rhinitis

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.

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.

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. FEV1 (forced expiratory volume in 1 s) <70% predicted at screening.
We found this trial at
1
site
West Los Angeles, California 90073
Principal Investigator: Joseph Stephen Yusin, MD
Phone: (310) 268-3528
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mi
from
West Los Angeles, CA
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