Ignite Creation Date:
2024-05-05 @ 11:08 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01269723
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2010-12-14
Brief Title:
Effects of Sulforaphane SFN on Immune Response to Live Attenuated Influenza Virus in Smokers and Nonsmokers
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Effects of Sulforaphane SFNon Innate Immune Responses to Live Attenuated Influenza Virus in Smokers and Nonsmokers
Status:
COMPLETED
Status Verified Date:
2014-01
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:
Vegetables such as broccoli cauliflower kale and cabbage are particularly rich in a plant chemical called sulforaphane SFN which boosts production of certain defense enzymes that increase the activity of antioxidants In animals the chemical protection from SFN helps prevent diseases associated with inflammation and cancer among others and this is currently being studied in humans
Young broccoli sprouts have a particularly high level of SFN compared to other foods The purpose of this research study is to learn about short term responses to live attenuated influenza virus LAIV administered to you via Flumist vaccine between smoking and nonsmoking volunteers treated with broccoli sprout homogenates shake or a placebo homogenate This will be done by obtaining a series of nasal lavages or rinses of your nose with salt water as well as 3 superficial biopsies of the inside lining of your nose both before and after you receive the vaccine Using these samples we will measure the amount of virus and the amount of inflammation in your nose and compare how smokers and nonsmokers respond to the vaccine when they are given a broccoli sprout homogenate high in SFN or a placebo alfalfa spout shake which is low in SFN during each of 4 study visits
Subjects will be seen for a screening visit inc HIV test and then randomly assigned to receive 1 of 2 homogenates Broccoli sprout homogenate will be the the active treatment arm while the placebo arm will be alfalfa sprout homogenate Two to 4 weeks after screening subjects will return for 5 sequential visits Monday-Friday Monday-Thursday they will receive the assigned homogenate On Tuesday they will receive the Flumistvaccine Subjects will also be seen at 1 and 3 weeks post vaccine Nasal lavage NL blood samples and nasal biopsies will performed prior to and after study interventions
Young broccoli sprouts have a particularly high level of SFN compared to other foods The purpose of this research study is to learn about short term responses to live attenuated influenza virus LAIV administered to you via Flumist vaccine between smoking and nonsmoking volunteers treated with broccoli sprout homogenates shake or a placebo homogenate This will be done by obtaining a series of nasal lavages or rinses of your nose with salt water as well as 3 superficial biopsies of the inside lining of your nose both before and after you receive the vaccine Using these samples we will measure the amount of virus and the amount of inflammation in your nose and compare how smokers and nonsmokers respond to the vaccine when they are given a broccoli sprout homogenate high in SFN or a placebo alfalfa spout shake which is low in SFN during each of 4 study visits
Subjects will be seen for a screening visit inc HIV test and then randomly assigned to receive 1 of 2 homogenates Broccoli sprout homogenate will be the the active treatment arm while the placebo arm will be alfalfa sprout homogenate Two to 4 weeks after screening subjects will return for 5 sequential visits Monday-Friday Monday-Thursday they will receive the assigned homogenate On Tuesday they will receive the Flumistvaccine Subjects will also be seen at 1 and 3 weeks post vaccine Nasal lavage NL blood samples and nasal biopsies will performed prior to and after study interventions
Detailed Description:
Schedule of visits
Prior to the screening visit subjects will be asked to avoid cruciferous vegetables list will be provided to them corticosteroids and nonsteroidal anti-inflammatory medications for 1 week prior to the initial visit and again for 1 week prior to all remaining visits They will to also be asked to avoid antioxidant vitamins as well as juicesdrinks with added vitamin supplements for 2 days prior to enrollment through study completion
Baseline screening obtain informed consent review medical history concomitant medications vital signs VSs urine collection for analysis of cotinine and SFN metabolites for all subjects and urine pregnancy test for females of child bearing potential all female subjects unless they are sp oophorectomy physical exam by study MD complete symptom scoring collect nasal lavage and nasal biopsy both nares buccal swab collection and venipuncture up to 75 ccs will be performed for human immunodeficiency virus HIV test baseline SFN level immune mediators and SFN-induced gene expression changes Food diaries will be provided with instructions for subjects at this visit
After successful completion of the screening the subject will be randomized to receive broccoli sprout homogenates or alfalfa sprout homogenates during the next 4 study visits Subjects will return 2-4 weeks after screening for 5 daily sequential visits Monday through Friday
Monday Day -1 VSs review of concomitant medications urine collection for analysis of cotinine and SFN metabolites for all subjects and Hcg for females of child bearing potential nasal lavage observed ingestion of initial dose and continue food diaries started 3 days prior
Tuesday Day 0 VSs symptomadverse event evaluation review of concomitant medications urine collection for analysis of cotinine and SFN metabolites observed ingestion of 2nd dose NL administration of LAIV continue food diaries
Wednesday Day 1 VSs symptomadverse event evaluation review of concomitant medications urine collection for analysis of cotinine and SFN metabolites observed ingestion of 3rd dose NL and continue food diaries
Thursday Day 2 VSs symptomadverse event evaluation review of concomitant medications and observed ingestion of 4th dose Two hours after ingestion urine collection for analysis of cotinine and SFN metabolites venipuncture up to 10 ccs for SFN level nasal biopsy left nare and NL will be performed Continue food diaries
Friday Day 3 VSs symptomadverse event evaluation review of concomitant medications urine collection for analysis of cotinine and SFN metabolites NL continue food diaries
Day 7 - 1 day VSs symptomadverse event evaluation review of concomitant medications urine collection for analysis of cotinine and SFN metabolites nasal biopsy right nare NL continue food diaries
Day 21 - 1 week VSs symptomadverse event evaluation review of concomitant medications urine collection for analysis of cotinine and SFN metabolites NL venipuncture up to 45 ccs for immune mediators as well as SFN-induced gene expression changes and anti-influenza antibody level collect completed food diary
Prior to the screening visit subjects will be asked to avoid cruciferous vegetables list will be provided to them corticosteroids and nonsteroidal anti-inflammatory medications for 1 week prior to the initial visit and again for 1 week prior to all remaining visits They will to also be asked to avoid antioxidant vitamins as well as juicesdrinks with added vitamin supplements for 2 days prior to enrollment through study completion
Baseline screening obtain informed consent review medical history concomitant medications vital signs VSs urine collection for analysis of cotinine and SFN metabolites for all subjects and urine pregnancy test for females of child bearing potential all female subjects unless they are sp oophorectomy physical exam by study MD complete symptom scoring collect nasal lavage and nasal biopsy both nares buccal swab collection and venipuncture up to 75 ccs will be performed for human immunodeficiency virus HIV test baseline SFN level immune mediators and SFN-induced gene expression changes Food diaries will be provided with instructions for subjects at this visit
After successful completion of the screening the subject will be randomized to receive broccoli sprout homogenates or alfalfa sprout homogenates during the next 4 study visits Subjects will return 2-4 weeks after screening for 5 daily sequential visits Monday through Friday
Monday Day -1 VSs review of concomitant medications urine collection for analysis of cotinine and SFN metabolites for all subjects and Hcg for females of child bearing potential nasal lavage observed ingestion of initial dose and continue food diaries started 3 days prior
Tuesday Day 0 VSs symptomadverse event evaluation review of concomitant medications urine collection for analysis of cotinine and SFN metabolites observed ingestion of 2nd dose NL administration of LAIV continue food diaries
Wednesday Day 1 VSs symptomadverse event evaluation review of concomitant medications urine collection for analysis of cotinine and SFN metabolites observed ingestion of 3rd dose NL and continue food diaries
Thursday Day 2 VSs symptomadverse event evaluation review of concomitant medications and observed ingestion of 4th dose Two hours after ingestion urine collection for analysis of cotinine and SFN metabolites venipuncture up to 10 ccs for SFN level nasal biopsy left nare and NL will be performed Continue food diaries
Friday Day 3 VSs symptomadverse event evaluation review of concomitant medications urine collection for analysis of cotinine and SFN metabolites NL continue food diaries
Day 7 - 1 day VSs symptomadverse event evaluation review of concomitant medications urine collection for analysis of cotinine and SFN metabolites nasal biopsy right nare NL continue food diaries
Day 21 - 1 week VSs symptomadverse event evaluation review of concomitant medications urine collection for analysis of cotinine and SFN metabolites NL venipuncture up to 45 ccs for immune mediators as well as SFN-induced gene expression changes and anti-influenza antibody level collect completed food diary
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 |
|---|---|---|---|
| R01HL095163-02 | NIH | None | httpsreporternihgovquickSearchR01HL095163-02 |