Early Phase 1
N=7
Pharmacokinetics of Benzo[a]Pyrene: Impact of Diet
Environmental Exposure
Bottom Line
View on ClinicalTrials.gov: NCT03802721 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Peak Plasma Concentration of 14C-BaP Cmax — 3.69; 1.67; 0.68 fg [14C]-BaP/mL plasma
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- [14C]-benzo[a]pyrene (Drug); Brussels sprouts before 50 ng dose (Drug); DIM supplement before 50 ng dose (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Oregon State University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Plasma Concentration of 14C-BaP Cmax |
3.69; 1.67; 0.68 | — |
| SECONDARY Time at Highest Plasma Concentration of 14C-BaP Tmax |
1.58; 1.14; 14.00 | — |
| SECONDARY Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC |
10.93; 9.34; 5.51 | — |
| SECONDARY Rate of Elimination of 14C-BaP (Half Life) |
3.69; 3.86; 9.75 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03802721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.