Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

NCT ID: NCT02999399

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2021-03-22

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.

Conditions

Smoking

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

[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.

Group Type: EXPERIMENTAL

Brussel Sprouts

Intervention Type: OTHER

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

Deuterated Phenanthrene

Intervention Type: 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.

Interventions

Brussel Sprouts

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

Intervention Type: OTHER

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naomi Fujioka, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1610M96281

Identifier Type: -

Identifier Source: org_study_id