Sulforaphane Supplementation in Atopic Asthmatics (brasma)

March 7, 2016 updated by: Michelle Hernandez, MD, University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Environmental Protection Agency at the University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sulforaphane-rich supplement
Intervention: broccosprout homogenate (rich in Sulforaphane) taken orally daily x 3 days
Dietary supplement: Sulforaphane Homogenate
Active
Placebo Comparator: Alfalfa Sprout Homogenate
Placebo: Alfalfa sprout homogenate taken daily x 3 days (poor in sulforaphane)
Dietary supplement: Alpha Sprout Homogenate
Alpha Sprout Homogenate
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 hours post third ingestion of SFN/placebo ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Michelle L Hernandez, MD, Center for Environmental Medicine Asthma and Lung Biology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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