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Sulforaphane Supplementation in Atopic Asthmatics (brasma)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alpha Sprout Homogenate
Sulforaphane Homogenate
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, Asthmatics, allergic, allergies

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-50 of both genders
  2. History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years.
  3. AND: Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine). Methacholine challenge in a separate screening protocol (98-0799), or from other venues will be accepted.
  4. OR: Pre and post bronchodilator FEV1 improvement by 12% or more after 4 puffs of albuterol inhaler.
  5. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma (NHANES III predicted set).
  6. Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response in a separate screening protocol. Proof of allergy from other venues, including ImmunoCAP testing from a medical workup, provided by the subject, will be accepted.
  7. Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg)
  8. Willing to provide information regarding health history and habits of cigarette smoke exposure;
  9. Willing to avoid antioxidant vitamins and cruciferous vegetables as well as juices/drinks with added vitamin supplements for 2 days prior the baseline screening visit and throughout initial dosing period.
  10. Subjects must be willing to avoid antihistamine use for 4 days prior to each session and NSAIDs for 7 days prior to each session. Nasal steroids must be held for 2 weeks prior to the session.

Exclusion Criteria:

  1. Medical history or underlying health problems that preclude participation in the protocol per the study physician;
  2. Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc;
  3. Use of oral corticosteroids within the past 4 weeks;
  4. Presence of upper or lower respiratory tract infection or treatment with antibiotics within the previous 4 weeks;
  5. Pregnancy as determined by menstrual history or urine pregnancy test;
  6. Current smokers will be excluded. Anyone with a smoking history > 0.5 pack year and/or >1 pack per month will also be excluded.
  7. History of bleeding disorder;
  8. Recent nasal surgery (with 6 months). If a subject has had nasal surgery between 6 months and 5 years, a study physician will visualize the area prior to the biopsy to evaluate the suitability of the nose for the procedure.
  9. History of intolerance of or aversion to broccoli
  10. Unable to withhold nasal steroids for 2 weeks before each session. These subjects may be deferred until after their allergy season.

Sites / Locations

  • Environmental Protection Agency at the University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sulforaphane-rich supplement

Alfalfa Sprout Homogenate

Arm Description

Intervention: broccosprout homogenate (rich in Sulforaphane) taken orally daily x 3 days

Placebo: Alfalfa sprout homogenate taken daily x 3 days (poor in sulforaphane)

Outcomes

Primary Outcome Measures

mRNA levels of NRF2 and NRF2-dependent phase II enzymes in nasal epithelial cells

Secondary Outcome Measures

Full Information

First Posted
April 17, 2013
Last Updated
March 7, 2016
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01845493
Brief Title
Sulforaphane Supplementation in Atopic Asthmatics
Acronym
brasma
Official Title
Sulforaphane Supplementation in Atopic Asthmatics
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will perform a pilot study of daily treatment with oral sulforaphane (SFN) for 3 days to determine if Nuclear factor (erythroid-derived 2)-like 2 (NRF2) induction is possible with this supplementation regimen in individuals with allergic asthma.
Detailed Description
This pilot study will examine if oral SFN supplementation can induce NRF2 and NRF2-dependent phase II enzymes in nasal epithelial cells of allergic asthmatics. Subjects will receive both a SFN-rich broccosprout homogenate preparation and an alfalfa sprout homogenate (placebo) in a crossover fashion. mRNA levels of NRF2 and NRF2-dependent phase II enzymes will be compared between the active and placebo periods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, Asthmatics, allergic, allergies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sulforaphane-rich supplement
Arm Type
Active Comparator
Arm Description
Intervention: broccosprout homogenate (rich in Sulforaphane) taken orally daily x 3 days
Arm Title
Alfalfa Sprout Homogenate
Arm Type
Placebo Comparator
Arm Description
Placebo: Alfalfa sprout homogenate taken daily x 3 days (poor in sulforaphane)
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha Sprout Homogenate
Other Intervention Name(s)
Placebo
Intervention Description
Alpha Sprout Homogenate
Intervention Type
Dietary Supplement
Intervention Name(s)
Sulforaphane Homogenate
Intervention Description
Active
Primary Outcome Measure Information:
Title
mRNA levels of NRF2 and NRF2-dependent phase II enzymes in nasal epithelial cells
Time Frame
2 hours post third ingestion of SFN/placebo ingestion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-50 of both genders History of episodic wheezing, chest tightness, or shortness of breath after age of 6 years consistent with asthma, or physician diagnosed asthma after age of 6 years. AND: Positive methacholine test. A positive test is defined as a provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in FEV1 (PC20 methacholine). Methacholine challenge in a separate screening protocol (98-0799), or from other venues will be accepted. OR: Pre and post bronchodilator FEV1 improvement by 12% or more after 4 puffs of albuterol inhaler. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of bronchodilating medications for 12 hours), consistent with lung function of persons with no more than mild episodic or mild persistent asthma (NHANES III predicted set). Allergic sensitization to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response in a separate screening protocol. Proof of allergy from other venues, including ImmunoCAP testing from a medical workup, provided by the subject, will be accepted. Oxygen saturation of > 94 % and normal blood pressure (Systolic between 150 - 90, Diastolic between 90-60 mm Hg) Willing to provide information regarding health history and habits of cigarette smoke exposure; Willing to avoid antioxidant vitamins and cruciferous vegetables as well as juices/drinks with added vitamin supplements for 2 days prior the baseline screening visit and throughout initial dosing period. Subjects must be willing to avoid antihistamine use for 4 days prior to each session and NSAIDs for 7 days prior to each session. Nasal steroids must be held for 2 weeks prior to the session. Exclusion Criteria: Medical history or underlying health problems that preclude participation in the protocol per the study physician; Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc; Use of oral corticosteroids within the past 4 weeks; Presence of upper or lower respiratory tract infection or treatment with antibiotics within the previous 4 weeks; Pregnancy as determined by menstrual history or urine pregnancy test; Current smokers will be excluded. Anyone with a smoking history > 0.5 pack year and/or >1 pack per month will also be excluded. History of bleeding disorder; Recent nasal surgery (with 6 months). If a subject has had nasal surgery between 6 months and 5 years, a study physician will visualize the area prior to the biopsy to evaluate the suitability of the nose for the procedure. History of intolerance of or aversion to broccoli Unable to withhold nasal steroids for 2 weeks before each session. These subjects may be deferred until after their allergy season.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle L Hernandez, MD
Organizational Affiliation
center for environmental medicine asthma and lung biology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Environmental Protection Agency at the University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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Sulforaphane Supplementation in Atopic Asthmatics

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