Pharmacokinetics of Benzo[a]Pyrene: Impact of Diet

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the pharmacokinetics for [14C]-benzo[a]pyrene ([14C]-BaP) and metabolites in plasma and urine over 48 hours following a 50 ng dose (5.4 nCi) alone, following 7 days' consumption of Brussels sprouts, and following 7 days' consumption of a supplement containing 3,3'-diindolylmethane (DIM).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon State University
• Collaborators: Lawrence Livermore National Laboratory; National Institute of Environmental Health Sciences (NIEHS); Pacific Northwest National Laboratory
• Treatments: 3,3'-diindolylmethane

Criteria

Inclusion Criteria:

• Age 21-65 (inclusive)

• If female, must be post-menopausal or have had surgical sterilization to eliminate any possibility for fetal exposure

• Willing to defer blood donation for one month before, throughout, and one month after completion of study activities

• Willing to avoid consuming cruciferous vegetables, I3C or DIM supplements, smoked or cured meat or cheeses, or charcoal-grilled meats for 2 weeks prior to and during each study cycle (gas grilled foods acceptable)

• Health history review and physical assessment showing general good health, as determined by study physician. Acceptable physical exam may have been conducted as part of protocol 8233 or 8554 if subject has not had significant changes in health status.

Exclusion Criteria:

• Smoker (tobacco or other substances) or use of smokeless tobacco in past 3 months or living with smoker

• Regular use of medications that affect gut motility or nutrient absorption (e.g. cholestyramine, sucralfate, orlistat, pro- or anti-motility agents)

• History of gastrointestinal surgery (e.g. bariatric surgery, cholecystectomy) or gastrointestinal disorder (Crohn's disease, celiac disease, IBS, or colitis)

• Current or history of kidney or liver disease

• Prior high-dose 14C exposure from medical tests. (micro-dose 14C exposure not exclusionary)

• Occupational PAH exposure (e.g. roofers, asphalt pavers, fire-fighters, etc.)

• Regular use of indole-3-carbinol or DIM dietary supplements

• Allergy or intolerance to Brussels sprouts or similar foods