Trial Outcomes & Findings for Broccoli Sprout Extract Effects on Allergic Inflammation in the Nose (NCT NCT00882115)

NCT ID: NCT00882115

Last Updated: 2019-09-20

Results Overview

Change of total nasal cell count in response to a standard diesel exhaust particle (DEP) challenge was determined by counting the total number of cells (leukocytes) recovered from nasal lavage fluid at 0 hr (just prior to DEP dosing), 6 hr and 24 hr later in participants who consuming BSE for 4 days, or without consuming BSE (control). Nasal challenges were performed with 300 microgram a standard DEP in 200 microliter saline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 0, 6 and 24 hours at Control visit and BSE visit (Day 4 of intervention)
• Results posted on: 2019-09-20

Participant Flow

The enrollment period was 07/10/2009 - 11/09/2010. Enrollment took place in a private setting in the clinic located at the site.

Thirty-eight participants who tested positive for cat allergy were enrolled. The study had three phases: screen, control and intervention. There was a 2-week run in and a 4-week wash out period. Six subjects who did not respond to DEP challenge at screen phase, and three subjects who withdrew from the study before intervention were excluded.

Participant milestones

Measure	Cell Count Change in Response to Nasal DEP Challenge. Nasal cell count change in response to DEP challenge (300 microgram DEP in 200 microliter saline) in participants who received BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
Overall Study STARTED	38
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Cell Count Change in Response to Nasal DEP Challenge. Nasal cell count change in response to DEP challenge (300 microgram DEP in 200 microliter saline) in participants who received BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
Overall Study Withdrawal by Subject	3
Overall Study did not respond to DEP challe	6

Baseline Characteristics

Broccoli Sprout Extract Effects on Allergic Inflammation in the Nose

Baseline characteristics by cohort

Measure	DEP Challenge in Subjects Consuming BSE n=29 Participants DEP will be administered in nostrils of participants who receive BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 6 and 24 hours at Control visit and BSE visit (Day 4 of intervention)

Population: All participants with baseline (0 hr), and 6 hr and 24 hr post-baseline nasal cell count measurement.

Change of total nasal cell count in response to a standard diesel exhaust particle (DEP) challenge was determined by counting the total number of cells (leukocytes) recovered from nasal lavage fluid at 0 hr (just prior to DEP dosing), 6 hr and 24 hr later in participants who consuming BSE for 4 days, or without consuming BSE (control). Nasal challenges were performed with 300 microgram a standard DEP in 200 microliter saline.

Outcome measures

Measure	Nasal DEP Challenge n=29 Participants All participants consumed 1.25 g BSE suspended in juice once a day for 4 consecutive days prior to dosing of 300 microg DEP in 200 microL saline
Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention 0 hr prior DEP dosing (control)	4.44 log cells/mL Standard Deviation 0.51
Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention 6 hr after DEP dosing (control)	4.50 log cells/mL Standard Deviation 0.56
Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention 24 hr after DEP dosing (control)	4.73 log cells/mL Standard Deviation 0.52
Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention 0 hr prior to DEP doising with BSE intervention	4.70 log cells/mL Standard Deviation 0.54
Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention 6 hr after DEP dosing with BSE intervention	4.44 log cells/mL Standard Deviation 0.51
Total Nasal Cell Count in Response to DEP Challenge at 0, 6 and 24 hr With or Without BSE Intervention 24 hr after DEP dosing with BSE intervention	4.57 log cells/mL Standard Deviation 0.46

Adverse Events

Cell Count Change in Response to Nasal DEP Challenge

Serious events: 5 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cell Count Change in Response to Nasal DEP Challenge n=38 participants at risk Nasal cell count change in response to DEP challenge (300 microgram DEP in 200 microliter saline) in participants who received BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
Gastrointestinal disorders mild discomfort	13.2% 5/38 • Number of events 8 • Adverse event data was collected over a 6 week period Participants were monitored and questioned regarding the occurrence and nature of any adverse experiences.

Other adverse events

Measure	Cell Count Change in Response to Nasal DEP Challenge n=38 participants at risk Nasal cell count change in response to DEP challenge (300 microgram DEP in 200 microliter saline) in participants who received BSE by drinking 1 cup of liquid containing 1.25 g BSE daily for 4 days, or without consuming BSE.
Skin and subcutaneous tissue disorders nasal irritation, running nose	10.5% 4/38 • Number of events 7 • Adverse event data was collected over a 6 week period Participants were monitored and questioned regarding the occurrence and nature of any adverse experiences.

Additional Information

Zhaoping Li

UCLA Department of Medicine/Center for Human Nutrition

Phone: 310-206-1987

Email: zli@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place