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Completed

NCT Number: NCT02999399

Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

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

Completed

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brussel Sprouts

Other

Subjects are given ~150 g of Brussels sprouts once daily for 7 consecutive days.

Deuterated phenanthrene

Drug

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.

Primary outcomes

  1. 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

  1. Change in [D10]phenanthrols

    Time frame: 7 days

    Compare level of urinary [D10]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.

  2. Change in [D10]phenanthrene tetraol:[D10]phenanthrol ratio

    Time frame: 7 days

    Compare level of urinary [D10]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.

Other outcomes

  1. Urinary 3,3'-diindolylmethane (DIM)

    Time frame: Day 3 and Day 6

    Urinary DIM will be quantified after Brussels sprout consumption on day 3 and day 6 of the feeding intervention for urinary DIM quantification

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2016
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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