Assessing the Effect of Glucobrassicin-Rich Brussels Sprouts on the Metabolism of Deuterated Phenanthrene: Developing Food-Based Chemoprevention of Tobacco-Related Lung Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Change in [D10]phenanthrene tetraol
Study Overview
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
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 (~200-300 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
[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.
Intervention: Deuterated Phenanthrene (Drug)
[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.
Intervention: Brussel Sprouts (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Change in [D10]phenanthrols(7 days)
- Change in [D10]phenanthrene tetraol:[D10]phenanthrol ratio(7 days)