Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing the Effect of Glucobrassicin-Rich Brussels Sprouts on the Metabolism of Deuterated Phenanthrene: Developing Food-Based Chemoprevention of Tobacco-Related Lung Cancer

Conditions
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Smoking

Intervention / Treatment
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* Other: Brussel Sprouts
* Drug: Deuterated Phenanthrene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [D10]phe and Brussels sprouts<br>All subjects are given 1 microgram [D10]phe before and after consuming Brussels sprouts once daily for 7 consecutive days. | Other: Brussel Sprouts<br>* Subjects are given  150 g of Brussels sprouts once daily for 7 consecutive days.<br>Drug: Deuterated Phenanthrene<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in [D10]phenanthrene tetraol | Compare level of urinary [D10]phenanthrene tetraol before and after 7 days of Brussels sprout consumption. | 7 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoker, Former smoker