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Effect of Sulforaphane-rich Broccoli Sprout Homogenate on Ozone Induced Inflammation Through Modulation of NRF2

NCT01625130 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-06-11

No results posted yet for this study

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 0.4 ppm O3 exposure. Participants will be randomized to received either the NRF2 modifier, SFN oral supplement (i.e. broccoli sprout shake), or placebo (alfalfa shake) for 3 days followed by a 0.4 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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Broccoli sprout homogenate

Commercially available Broccosprouts® (Brassica Protection Products LLC) will be homogenized with water using a ratio of 1:1.2 in a clean blender. The homogenate will then be frozen in aliquots at -20 degrees C.

DIETARY_SUPPLEMENT

alfalfa sprout homogenate

200 grams of alfalfa sprouts will be homogenized with water using a ratio of 1:1.2 in a clean blender. The homogenate will then be frozen in aliquots at -20 degrees C.

Sponsors & Collaborators

  • Environmental Protection Agency (EPA)

    collaborator FED

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Michelle Hernandez · University of North Carolina, Chapel Hill School of Medicine

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01625130 on ClinicalTrials.gov