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Effects of Broccoli Sprout Extract on Allergy Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02885025
Recruitment Status : Completed
First Posted : August 31, 2016
Results First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Rhinitis,Allergic Dietary Supplement: Broccoli Sprout Extract Drug: fluticasone nasal Dietary Supplement: broccoli sprout extract placebo Drug: normal saline nasal spray Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Broccoli Sprout Extract on Allergic Rhinitis
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : March 12, 2019
Actual Study Completion Date : March 12, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fluticasone

Arm Intervention/treatment
Active Comparator: BSE + Nasal Fluticasone

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
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.

Active Comparator: Broccoli Sprout Extract + 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
Dietary Supplement: Broccoli Sprout Extract
Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.

Drug: normal saline nasal spray
normal saline to replace nasal fluticasone in specific arms of the study

Active Comparator: Placebo Pill + Nasal Fluticasone

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

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.

Placebo Comparator: 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
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




Primary Outcome Measures :
  1. Total Nasal Symptom Score (TNSS) Change From Baseline to 3 Weeks of Randomly Assigned Treatment [ Time Frame: measures at various points following challenge at baseline and 21 days ]
    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.

  2. Peak Nasal Inspiratory Flow (PNIF) Change From Baseline to 3 Weeks of Randomly Assigned Treatment [ Time Frame: 21 days (from randomization to completion) ]
    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 :
  1. Interleukin 5 (IL5) [ Time Frame: 21 days (from randomization to completion) ]
    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.

  2. Interleukin 4 (IL4) [ Time Frame: 21 days (from randomization to completion) ]
    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.

  3. Interleukin 6 (IL6) [ Time Frame: 21 days (from randomization to completion) ]
    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.

  4. Interleukin 8 (IL8) [ Time Frame: 21 days (from randomization to completion) ]
    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.

  5. Interleukin 13 (IL13) [ Time Frame: 21 days (from randomization to completion) ]
    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.

  6. Interleukin 1 Beta (IL1b) [ Time Frame: 21 days (from randomization to completion) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885025


Locations
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United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Zhaoping Li, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Principal Investigator: Joseph Stephen Yusin, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Informed Consent Form  [PDF] November 19, 2018

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02885025    
Other Study ID Numbers: CLNB-03-15F
First Posted: August 31, 2016    Key Record Dates
Results First Posted: June 19, 2020
Last Update Posted: June 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
hypersensitivity
antioxidants
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents