Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

Smoking Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999399
• Other study ID #: 1610M96281
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2016
• Est. completion date: March 22, 2021

Study information

• Verified date: February 2023
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Change in [D10]phenanthrene tetraol	Compare level of urinary [D10]phenanthrene tetraol before and after 7 days of Brussels sprout consumption.	7 days
Secondary	Change in [D10]phenanthrols	Compare level of urinary [D10]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.	7 days
Secondary	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