Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

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

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

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: Brussel Sprouts; Drug: Deuterated Phenanthrene

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary 3,3'-diindolylmethane (DIM)	Urinary DIM will be quantified after Brussels sprout consumption on day 3 and day 6 of the feeding intervention for urinary DIM quantification	Day 3 and Day 6

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 22, 2021
• Study Completion (Actual): March 22, 2021

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: December 16, 2016
• First Posted (Estimate): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Smoker; Former smoker
• Other Study ID Numbers: 1610M96281

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No