Viewing Study NCT01625130



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Last Modification Date: 2024-10-26 @ 10:52 AM
Study NCT ID: NCT01625130
Status: COMPLETED
Last Update Posted: 2015-06-11
First Post: 2012-06-19

Brief Title: Effect of Sulforaphane-rich Broccoli Sprout Homogenate on Ozone Induced Inflammation Through Modulation of NRF2
Sponsor: University of North Carolina Chapel Hill
Organization: University of North Carolina Chapel Hill

Study Overview

Official Title: Down Regulation of Oxidant Induced Airway Inflammation Through Modulation of NRF2
Status: COMPLETED
Status Verified Date: 2015-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BroccOz
Brief Summary: Purpose To determine if modulation of NRF2 with a Sulforaphane enriched supplement modifies responses to O3 Participants Recruitment of up to 70 healthy volunteers ages 18-50 for completion of 36 volunteers Procedures This is a randomized placebo controlled 2x2 crossover study of treatment with an NRF2 modifier versus placebo in healthy volunteers which will examine airway inflammation before and 4 hours after a 2 hour 04 ppm O3 exposure Participants will be randomized to received either the NRF2 modifier SFN oral supplement ie broccoli sprout shake or placebo alfalfa shake for 3 days followed by a 04 ppm O3 exposure for 2 hours At least 2 weeks later subjects will return for a 2nd supplementation treatment using the alternative supplement to that provided initially followed by an ozone exposure identical to the initial one
Detailed Description: Potential subjects will be seen for a baseline screening visit at which time informed consent will be obtained a 12 lead ECG will be performed and spirometry with subsequent sputum induction will be performed Only subjects meeting the lung function criteria as well as criteria for adequate sputum production will continue in the study If the sample is considered borderline by the study team the subject maybe invited back to repeat collection of another sputum sample Subjects will be required to abstain from caffeine for 12 hours prior to all study visits and must not useingest non-steroidal anti-inflammatory medications anti-oxidant vitamins juicesdrinks fortified with extra vitamin supplement and cruciferous vegetables 7 days prior to all visits Subjects will be provided with a list of cruciferous vegetables

Qualified volunteers will next be seen for a training visit at which time they will undergo physical exam by a study physician After baseline spirometry is evaluated the subject will exercise on a treadmill and measurements of minute ventilation will be collected Treadmill speed andor elevation will be adjusted until the subjects minute ventilation is at the target level of 30-40 Lmin The resulting speed and elevation will be used during the ozone exposure sessions At the training visit participants will also undergo nasal epithelial biopsy from one nare and a buccal swab will be collected for genotyping Baseline blood samples will also be collected at this time for analyses of markers of inflammation cytokine assessments SFN levels and complete blood cell count with differential

After completion of the training session the subject will return for 4 sequential days During the first 3 days subjects will ingest observed ingestion either broccoli sprout homogenate or alfalfa sprout homogenate based on earlier randomization One hour after the supplement dose on the 3rd day the volunteer will undergo exposure to 04 ppm ozone for a 2 hour period During exposure subjects will perform 15 minutes of moderate exercise on a treadmill minute ventilation 30-40 Lmin each separated by 15 minutes of seated rest Heart rate and rhythm will be continuously monitored throughout the exposure Spirometry and symptom scoring will be performed both prior to and after exposure One hour after the end of exposure a nasal epithelial biopsy will be collected from the nare that is contralateral to that used at the prior visit Four hours after completion of the exposure blood will be drawn for study endpoints and a sputum induction will be performed The following day the subject will return for a follow-up visit to include vital signs symptom scoring spirometry sputum induction and venipuncture for blood endpoints

Subjects will be required to abstain from a list of vegetables for 1 week prior to each study session until the completion of that session Subjects will also be asked to maintain a food diary for the same time

After a 2 to 6 weeks washout period participants will again return for a repeated sequence of 4 days with 3 days of supplement ingestion followed by ozone exposure using the alternate supplement and a 24 hour post exposure follow-up visit Samples for analyses will be collected at the same time points as those used in the initial sequence

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None