Sulforaphane Supplementation in Atopic Asthmatics

NCT01845493 | Completed Phase 1

• 1 other identifier: 13-0056
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; Asthmatics; allergic; allergies

Outcome Measures

Primary Outcomes (1)

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

  2 hours post third ingestion of SFN/placebo ingestion

Study Arms (2)

Sulforaphane-rich supplement

ACTIVE COMPARATOR

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

Dietary Supplement: Sulforaphane Homogenate

Alfalfa Sprout Homogenate

PLACEBO COMPARATOR

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

Dietary Supplement: Alpha Sprout Homogenate

Interventions

Alpha Sprout Homogenate DIETARY_SUPPLEMENT

Alpha Sprout Homogenate

Also known as: Placebo

Alfalfa Sprout Homogenate

Sulforaphane Homogenate DIETARY_SUPPLEMENT

Active

Sulforaphane-rich supplement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

Environmental Protection Agency at the University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Michelle L Hernandez, MD

  center for environmental medicine asthma and lung biology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 9, 2016

Record last verified: 2016-03

Locations

US (1)