Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

Phase 1

Completed

• Conditions: Smoking
• Interventions: Other: Brussel Sprouts; Drug: Deuterated Phenanthrene

• Registration Number: NCT02999399
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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 Timeline

• Study First Submitted: 2016-11-15
• Study Start: 2016-12-01
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-21
• Primary Completion: 2021-03-22
• Study Completion: 2021-03-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[D10]phe and Brussels sprouts	Deuterated Phenanthrene	All subjects are given 1 microgram \[D10\]phe before and after consuming Brussels sprouts once daily for 7 consecutive days.
[D10]phe and Brussels sprouts	Brussel Sprouts	All subjects are given 1 microgram \[D10\]phe before and after consuming Brussels sprouts once daily for 7 consecutive days.

Primary Outcome Measures

Name	Time	Method
Change in [D10]phenanthrene tetraol	7 days	Compare level of urinary \[D10\]phenanthrene tetraol before and after 7 days of Brussels sprout consumption.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States