Viewing Study NCT01129466



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Last Modification Date: 2024-10-26 @ 10:20 AM
Study NCT ID: NCT01129466
Status: COMPLETED
Last Update Posted: 2013-02-15
First Post: 2010-05-21

Brief Title: Effects of 2 Different Broccoli Sprout Containing Supplements on Nasal Cells in Healthy Volunteers
Sponsor: University of North Carolina Chapel Hill
Organization: University of North Carolina Chapel Hill

Study Overview

Official Title: Effects of Sulforaphane Containing Supplements on Nasal Cell Phase 2 Gene Expression in Healthy Volunteers
Status: COMPLETED
Status Verified Date: 2013-02
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: Broccosprout
Brief Summary: Purpose To compare the change in nasal cell HO-1 expression induced by two different preparations of sulforaphane SFN-containing nutritional supplements Participants Healthy nonsmoking young adults age 18-35 Procedures methods This pilot study will use a randomized crossover design Subjects will be randomized to receive either the equivalent of 4 ouncesday of fresh broccoli sprouts FBS in food and tea or the equivalent amount as broccoli sprout homogenates BSH for 3 consecutive days Nasal lavage and blood samples will be obtained before during and after this 3-day period After at least a 2-week washout interval the protocol will be repeated with the alternate supplement The primary analysis will test the hypothesis that broccoli sprouts in food will increase HO-1 expression to a similar degree as the equivalent amount of sprouts in BSH
Detailed Description: Broccoli sprouts are a concentrated source of the potent phase 2 enzyme antioxidant potentiator sulforaphane SFN in the form of its natural precursor sulforaphane glucosinolate SGS SFN is an isothiocyanate which has generated interest recently as a chemopreventive agent in cancer research and as an antioxidant in inflammation research Recently published data show that 3 days intake of broccoli sprouts in homogenate form is followed by significant upregulation of several phase 2 enzymes in nasal cells Our groups research at the UNC Center for Environmental Medicine Asthma and Lung Biology CEMALB focuses on the effects of oxidant pollutants on inflammatory and host defense responses to viral infections One of the aims of our grant is to measure the effects of pre-treatment with SFN supplements on nasal responses to live attenuated influenza virus vaccines In preparation for this larger study we here propose a pilot study comparing the effects of the published BSH supplement vs supplementation with foods containing fresh broccoli sprouts on relevant nasal endpoints and serum SFN levels

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
1R01HL095163-01A2 NIH None httpsreporternihgovquickSearch1R01HL095163-01A2