Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

NCT02999399 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 1610M96281
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Smoking

Keywords

Smoker; Former smoker

Outcome Measures

Primary Outcomes (1)

• Change in [D10]phenanthrene tetraol

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

  7 days

Secondary Outcomes (2)

• Change in [D10]phenanthrols

  7 days

• Change in [D10]phenanthrene tetraol:[D10]phenanthrol ratio

  7 days

Other Outcomes (1)

• Urinary 3,3'-diindolylmethane (DIM)

  Day 3 and Day 6

Study Arms (1)

[D10]phe and Brussels sprouts

EXPERIMENTAL

All subjects are given 1 microgram \[D10\]phe before and after consuming Brussels sprouts once daily for 7 consecutive days.

Other: Brussel Sprouts; Drug: Deuterated Phenanthrene

Interventions

Brussel Sprouts OTHER

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

[D10]phe and Brussels sprouts

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.

[D10]phe and Brussels sprouts

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Naomi Fujioka, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: December 21, 2016
• Study Start: December 1, 2016
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

US (1)