Ignite Creation Date:
2024-05-05 @ 10:46 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01183923
Status:
TERMINATED
Last Update Posted:
2019-06-04
First Post:
2010-08-17
Brief Title:
Dietary Interventions in Asthma Treatment Sprouts Study
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Dietary Interventions in Asthma Treatment Sprouts Study
Status:
TERMINATED
Status Verified Date:
2019-05
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:
None
Brief Summary:
Sulforaphane SFN is a naturally occurring isothiocyanate that is a potent inducer of Phase II enzymes which play a critical role in preventing oxidative stress via activation of Nrf2 Broccoli sprouts BS contain the richest source of SFN
The main objectives of this study are to test the effect of broccoli sprouts BS on biomarkers of oxidative stress OS inflammation basophil activation and clinical outcomes in mouse allergen-induced asthma by 1 determining if BS improves lung function and airways symptom responses in mouse-sensitized adults with asthma undergoing environmental mouse allergen challenge EMAC 2 examining the effect of BS on OS inflammation and basophil activation and 3 examining the effect of BS on changes in OS inflammation and basophil activation after EMAC
The main objectives of this study are to test the effect of broccoli sprouts BS on biomarkers of oxidative stress OS inflammation basophil activation and clinical outcomes in mouse allergen-induced asthma by 1 determining if BS improves lung function and airways symptom responses in mouse-sensitized adults with asthma undergoing environmental mouse allergen challenge EMAC 2 examining the effect of BS on OS inflammation and basophil activation and 3 examining the effect of BS on changes in OS inflammation and basophil activation after EMAC
Detailed Description:
After eligibility is confirmed participants will be randomized to a placebo then BS or b BS then placebo At randomization baseline exhaled nitric oxide eNO forced expiratory volume at one second FEV1 nasal epithelial gene expression urinary OS biomarkers serum inflammatory and OS biomarkers and basophil activation will be assessed These will be assessed again after 7 days on the assigned intervention at two time points pre- and post-EMAC The 1 week time period was chosen because previous studies have shown that daily ingestion of a broccoli sprout homogenate for three days resulted in upregulation of phase II enzyme gene expression in nasal epithelial cells Following a 2-week washout period this protocol will be repeated for the second intervention phase II The 2 week washout period will be sufficient as the half life of the extract of the active ingredient in broccoli sprouts SFN has been shown to be 18 hours16 Participants diets will be assessed before and after each intervention with a Food Frequency Questionnaire and a questionnaire to capture intake of specific foods that are rich in SFN
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P01ES018176-01 | NIH | None | httpsreporternihgovquickSearch1P01ES018176-01 |