Clinical trial NCT02999399: Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking
Keywords: Smoker
Former smoker
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Change in [D10]phenanthrene tetraol
timeFrame: 7 days
Secondary outcomes:
measure: Change in [D10]phenanthrols
timeFrame: 7 days
measure: Change in [D10]phenanthrene tetraol:[D10]phenanthrol ratio
timeFrame: 7 days
Other outcomes:
measure: Urinary 3,3'-diindolylmethane (DIM)
timeFrame: Day 3 and Day 6
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Naomi Fujioka, MD
role: PRINCIPAL_INVESTIGATOR
References: