Sulforaphane Supplementation in Atopic Asthmatics (brasma)

• ClinicalTrials.gov Identifier: NCT01845493
• Recruitment Status: Completed
• First Posted: May 3, 2013
• Last Update Posted: March 9, 2016
• Sponsor: University of North Carolina, Chapel Hill
• Information provided by (Responsible Party): Michelle Hernandez, MD, University of North Carolina, Chapel Hill

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Dietary Supplement: Alpha Sprout Homogenate; Dietary Supplement: Sulforaphane Homogenate	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Sulforaphane Supplementation in Atopic Asthmatics
• Study Start Date: April 2013
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

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 Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, North Carolina

Environmental Protection Agency at the University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Michelle L Hernandez, MD; center for environmental medicine asthma and lung biology

More Information

• Responsible Party: Michelle Hernandez, MD, Principle Investigator, University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT01845493
• Other Study ID Numbers: 13-0056
• First Posted: May 3, 2013
• Last Update Posted: March 9, 2016
• Last Verified: March 2016

Keywords provided by Michelle Hernandez, MD, University of North Carolina, Chapel Hill:

asthma; Asthmatics; allergic; allergies

Additional relevant MeSH terms:

Sulforaphane; Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Anticarcinogenic Agents; Protective Agents; Physiological Effects of Drugs; Antineoplastic Agents