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Effects of Broccoli Sprout Extract on Allergy Rhinitis

Primary Purpose

Rhinitis,Allergic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Broccoli Sprout Extract
fluticasone nasal
broccoli sprout extract placebo
normal saline nasal spray
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis,Allergic focused on measuring hypersensitivity, antioxidants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

BSE + Nasal Fluticasone

Broccoli Sprout Extract + normal saline nasal spray

Placebo Pill + Nasal Fluticasone

Placebo Pill + normal saline nasal spray

Arm Description

subjects will be randomized into 1 of 4 arms: Broccoli Sprout Extract + Nasal Fluticasone Broccoli Sprout Extract + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray

subjects will be randomized into 1 of 4 arms: Broccoli Sprout Extract + Nasal Fluticasone Broccoli Sprout Extract + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray

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

subjects will be randomized into 1 of 4 arms: Broccoli Sprout Extract + Nasal Fluticasone Broccoli Sprout Extract + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 23, 2016
Last Updated
May 26, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02885025
Brief Title
Effects of Broccoli Sprout Extract on Allergy Rhinitis
Official Title
Effects of Broccoli Sprout Extract on Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
March 12, 2019 (Actual)
Study Completion Date
March 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis,Allergic
Keywords
hypersensitivity, antioxidants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BSE + Nasal Fluticasone
Arm Type
Active Comparator
Arm Description
subjects will be randomized into 1 of 4 arms: Broccoli Sprout Extract + Nasal Fluticasone Broccoli Sprout Extract + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray
Arm Title
Broccoli Sprout Extract + normal saline nasal spray
Arm Type
Active Comparator
Arm Description
subjects will be randomized into 1 of 4 arms: Broccoli Sprout Extract + Nasal Fluticasone Broccoli Sprout Extract + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray
Arm Title
Placebo Pill + Nasal Fluticasone
Arm Type
Active Comparator
Arm 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
Arm Title
Placebo Pill + normal saline nasal spray
Arm Type
Placebo Comparator
Arm Description
subjects will be randomized into 1 of 4 arms: Broccoli Sprout Extract + Nasal Fluticasone Broccoli Sprout Extract + normal saline nasal spray Placebo Pill + Nasal Fluticasone Placebo Pill + normal saline nasal spray
Intervention Type
Dietary Supplement
Intervention Name(s)
Broccoli Sprout Extract
Intervention Description
Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
Intervention Type
Drug
Intervention Name(s)
fluticasone nasal
Intervention Description
fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
Intervention Type
Dietary Supplement
Intervention Name(s)
broccoli sprout extract placebo
Intervention Description
a tablet similar to the actual broccoli sprout extract though without BSE.
Intervention Type
Drug
Intervention Name(s)
normal saline nasal spray
Intervention Description
normal saline to replace nasal fluticasone in specific arms of the study
Primary Outcome Measure Information:
Title
Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
Description
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.
Time Frame
measures at various points following challenge at baseline and 21 days
Title
Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment
Description
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).
Time Frame
21 days (from randomization to completion)
Secondary Outcome Measure Information:
Title
Interleukin 5 (IL5)
Description
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.
Time Frame
21 days (from randomization to completion)
Title
Interleukin 4 (IL4)
Description
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.
Time Frame
21 days (from randomization to completion)
Title
Interleukin 6 (IL6)
Description
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.
Time Frame
21 days (from randomization to completion)
Title
Interleukin 8 (IL8)
Description
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.
Time Frame
21 days (from randomization to completion)
Title
Interleukin 13 (IL13)
Description
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.
Time Frame
21 days (from randomization to completion)
Title
Interleukin 1 Beta (IL1b)
Description
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.
Time Frame
21 days (from randomization to completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoping Li, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Stephen Yusin, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Broccoli Sprout Extract on Allergy Rhinitis

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