Effects of Broccoli Sprout Extract on Allergy Rhinitis

Rhinitis,Allergic Clinical Trial

Official title:

Effects of Broccoli Sprout Extract on Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885025
• Other study ID #: CLNB-03-15F
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2016
• Est. completion date: March 12, 2019

Study information

• Verified date: May 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 12, 2019
• Est. primary completion date: March 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis,Allergic

Intervention

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

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment	The Immediate Total Nasal Symptom Score (TNSS): The TNSS has been used in prior interventional studies to evaluate different treatment modes for allergic rhinitis. The score will consist of subjects rating 4 symptoms (nasal congestion/postnasal drainage, nasal pruritus, rhinorrhea, or sneezing) on a scale of 0 to 3, where 0=no symptoms present, 1=mild symptoms that do not interfere with activity, 2=moderate symptoms that are slightly bothersome symptoms with slight interference with activity and/or nighttime sleep, or 3=severe symptoms with interference with activity and nighttime sleep. Thus minimal value would be 0 vs. maximal value would be a score of 12. A higher score correlates with higher rhinitis activity. Diminished scores following an intervention is consistent with an improvement in rhinitis symptoms.	measures at various points following challenge at baseline and 21 days
Primary	Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment	peak nasal inspiratory flow (PNIF) measures the peak flow during nasal inspiration with an approved device utilized in other studies. Measurements will be performed with TNSS (above).	21 days (from randomization to completion)
Secondary	Interleukin 5 (IL5)	Interleukin 5 (IL5) is considered a T2 cytokine that increases with exacerbations of atopic disease, including allergic rhinitis. Cytokine measurements are in pg/ml. Values are recorded with log transformation. Note that measurements are on a continuous score. Lower values are consistent with less T2 inflammation which is consistent with diminished or lower atopic/allergic response.	21 days (from randomization to completion)
Secondary	Interleukin 4 (IL4)	Interleukin 4 (IL4) is considered a T2 cytokine that increases with exacerbations of atopic disease, including allergic rhinitis. Cytokine measurements are in pg/ml. Values are recorded with log transformation. Note that measurements are on a continuous score. Lower values are consistent with less T2 inflammation which is consistent with diminished or lower atopic/allergic response.	21 days (from randomization to completion)
Secondary	Interleukin 6 (IL6)	Interleukin 6 is a cytokine present during inflammatory process. This is recorded in pg/ml. Below is the log transformation of the pg/ml unit. Note that measurements are on a continuous score. Lower values are consistent with less inflammation which could occur with an inflammatory response.	21 days (from randomization to completion)
Secondary	Interleukin 8 (IL8)	Interleukin 8 s a cytokine that will increase with inflammation. Below is the log transformation of the pg/ml unit. Note that measurements are on a continuous score. Lower values are consistent with less inflammation which could occur with an inflammatory response.	21 days (from randomization to completion)
Secondary	Interleukin 13 (IL13)	Interleukin 13 (IL13) is considered a T2 cytokine that increases with exacerbations of atopic disease, including allergic rhinitis. Cytokine measurements are in pg/ml. Values are recorded with log transformation. Note that measurements are on a continuous score. Lower values are consistent with less T2 inflammation which is consistent with diminished or lower atopic/allergic response.	21 days (from randomization to completion)
Secondary	Interleukin 1 Beta (IL1b)	IL1b is a cytokine that will increase with inflammation. Below is the log transformation of the pg/ml unit. Note that measurements are on a continuous score. Lower values are consistent with less inflammation which could occur with an inflammatory response.	21 days (from randomization to completion)