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Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

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ClinicalTrials.gov Identifier: NCT02999399
Recruitment Status : Active, not recruiting
First Posted : December 21, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
To determine whether glucobrassicin-rich Brussels sprouts can favorably modify the metabolism of the polycyclic aromatic hydrocarbon deuterated phenanthrene ([D10]phe) in current and former smokers

Condition or disease Intervention/treatment Phase
Smoking Other: Brussel Sprouts Drug: Deuterated Phenanthrene Not Applicable

Detailed Description:
Subjects will be given 1 microgram of [D10]phe, and all urine will be collected for 6 h afterwards to quantify baseline levels of [D10]phenanthrene tetraol ([D10]pheT) and [D10]phenanthrols ([D10]HOP). Within 3 days of this baseline measurement, subjects will consume 200 micromoles of glucobrassicin in the form of raw Brussels sprouts (~150 grams) at the study center once daily for 7 consecutive days. Urine will be collected for 24 h after vegetable consumption on days 3 ± 1 and 6 of the feeding intervention for 3,3'-diindolylmethane (DIM) quantification. On day 7 of the feeding intervention, a second dose of 1 microgram of [D10]phe will be administered at the study center after vegetable consumption, followed by another 6 h urine collection.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessing the Effect of Glucobrassicin-Rich Brussels Sprouts on the Metabolism of Deuterated Phenanthrene: Developing Food-Based Chemoprevention of Tobacco-Related Lung Cancer
Study Start Date : December 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: [D10]phe and Brussels sprouts
All subjects are given 1 microgram [D10]phe before and after consuming Brussels sprouts once daily for 7 consecutive days.
Other: Brussel Sprouts
Subjects are given ~150 g of Brussels sprouts once daily for 7 consecutive days.
Drug: Deuterated Phenanthrene
Subjects are given 1 microgram of deuterated phenanthrene [D10]phe at baseline and after 7 days of Brussels sprout consumption. Urine is collected for 6 hours after each dose.



Primary Outcome Measures :
  1. Change in [D10]phenanthrene tetraol [ Time Frame: 7 days ]
    Compare level of urinary [D10]phenanthrene tetraol before and after 7 days of Brussels sprout consumption.


Secondary Outcome Measures :
  1. Change in [D10]phenanthrols [ Time Frame: 7 days ]
    Compare level of urinary [D10]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.

  2. Change in [D10]phenanthrene tetraol:[D10]phenanthrol ratio [ Time Frame: 7 days ]
    Compare level of urinary [D10]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.


Other Outcome Measures:
  1. Urinary 3,3'-diindolylmethane (DIM) [ Time Frame: Day 3 and Day 6 ]
    Urinary DIM will be quantified after Brussels sprout consumption on day 3 and day 6 of the feeding intervention for urinary DIM quantification



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult ≥ 18 years old
  • Current or former smoker by self-report
  • Willing to abstain from cruciferous vegetable consumption other than the study vegetable during the study period
  • Able to understand the experimental nature of the study and provide informed consent
  • Negative urine pregnancy test for women of childbearing potential within 7 days of baseline [D10]phe dosing

Exclusion Criteria:

  • Chronic proton pump inhibitor, H2-blocker (i.e., ranitidine, famotidine), and/or calcium carbonate use
  • History of gastric bypass surgery, gastric banding, bowel resection, malabsorption syndromes such as celiac sprue or pancreatic insufficiency, or other conditions that may affect gastric absorption
  • Current use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes) or use of these products within 3 months of study registration
  • Major or chronic medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigator
  • Women who are pregnant, intend to become pregnant within 3 months of the study period, or who are breastfeeding
  • Current or recent (within 12 months) problems with drug use or alcohol dependence by self-report Antibiotic use within 2 months of study enrollment or during the study by self-report Alcohol dependence, abuse, or history of dependence/abuse by self-report Vegetarians
  • History of respiratory tract cancer
  • Use of metronidazole or antabuse during the study
  • Taking ibuprofen, naproxen, other NSAIDs, steroids (except inhaled steroids) within 14 days of study registration
  • Allergy to Brussels sprouts

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999399


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Naomi Fujioka, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02999399     History of Changes
Other Study ID Numbers: D10
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Smoker
Former smoker