Trial Outcomes & Findings for Pharmacokinetics of Benzo[a]Pyrene: Impact of Diet (NCT NCT03802721)
NCT ID: NCT03802721
Last Updated: 2025-06-22
Results Overview
Determination of highest concentration of 14C-BaP in plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine Cmax.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
7 participants
Primary outcome timeframe
0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycle
Results posted on
2025-06-22
Participant Flow
Participant milestones
| Measure |
50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose
Cycle 1: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Subjects will consume 50 g (about 1/2 cup) of lightly steamed Brussels sprouts each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 3: Subjects will consume 300 mg DIM supplement ( 2 capsules of BioResponse DIM® 150) each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP). A 300 mg DIM dose will be co-administrated with the 50 ng BaP dose.
At least 3 weeks will pass between cycles as a washout period.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
Brussels sprouts before 50 ng dose: Brussels sprouts for 7 days before 50 ng (5.4 nCi) dose of BaP
DIM supplement before 50 ng dose: DIM supplement for 7 days before 50 ng (5.4 nCi) dose of BaP and coadministration with DIM supplement
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics of Benzo[a]Pyrene: Impact of Diet
Baseline characteristics by cohort
| Measure |
50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose
n=7 Participants
Cycle 1: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Subjects will consume 50 g (about 1/2 cup) of lightly steamed Brussels sprouts each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 3: Subjects will consume 300 mg DIM supplement ( 2 capsules of BioResponse DIM® 150) each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP). A 300 mg DIM dose will be co-administrated with the 50 ng BaP dose.
At least 3 weeks will pass between cycles as a washout period.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
Brussels sprouts before 50 ng dose: Brussels sprouts for 7 days before 50 ng (5.4 nCi) dose of BaP
DIM supplement before 50 ng dose: DIM supplement for 7 days before 50 ng (5.4 nCi) dose of BaP and coadministration with DIM supplement
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycleDetermination of highest concentration of 14C-BaP in plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine Cmax.
Outcome measures
| Measure |
50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose
n=7 Participants
Cycle 1: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Subjects will consume 50 g (about 1/2 cup) of lightly steamed Brussels sprouts each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 3: Subjects will consume 300 mg DIM supplement ( 2 capsules of BioResponse DIM® 150) each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP). A 300 mg DIM dose will be co-administrated with the 50 ng BaP dose.
At least 3 weeks will pass between cycles as a washout period.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
Brussels sprouts before 50 ng dose: Brussels sprouts for 7 days before 50 ng (5.4 nCi) dose of BaP
DIM supplement before 50 ng dose: DIM supplement for 7 days before 50 ng (5.4 nCi) dose of BaP and coadministration with DIM supplement
|
|---|---|
|
Peak Plasma Concentration of 14C-BaP Cmax
50 ng [14C] BaP
|
3.69 fg [14C]-BaP/mL plasma
Standard Deviation 4.12
|
|
Peak Plasma Concentration of 14C-BaP Cmax
Brussels sprouts before 50 ng [14C] BaP
|
1.67 fg [14C]-BaP/mL plasma
Standard Deviation 1.03
|
|
Peak Plasma Concentration of 14C-BaP Cmax
DIM supplement before 50 ng [14C] BaP
|
0.68 fg [14C]-BaP/mL plasma
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycleDetermination of time at which plasma concentration of 14C-BaP is highest. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine Tmax.
Outcome measures
| Measure |
50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose
n=7 Participants
Cycle 1: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Subjects will consume 50 g (about 1/2 cup) of lightly steamed Brussels sprouts each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 3: Subjects will consume 300 mg DIM supplement ( 2 capsules of BioResponse DIM® 150) each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP). A 300 mg DIM dose will be co-administrated with the 50 ng BaP dose.
At least 3 weeks will pass between cycles as a washout period.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
Brussels sprouts before 50 ng dose: Brussels sprouts for 7 days before 50 ng (5.4 nCi) dose of BaP
DIM supplement before 50 ng dose: DIM supplement for 7 days before 50 ng (5.4 nCi) dose of BaP and coadministration with DIM supplement
|
|---|---|
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Time at Highest Plasma Concentration of 14C-BaP Tmax
50 ng [14C] BaP
|
1.58 hour
Standard Deviation 1.16
|
|
Time at Highest Plasma Concentration of 14C-BaP Tmax
Brussels sprouts before 50 ng [14C] BaP
|
1.14 hour
Standard Deviation 0.90
|
|
Time at Highest Plasma Concentration of 14C-BaP Tmax
DIM supplement before
|
14.00 hour
Standard Deviation 19.17
|
SECONDARY outcome
Timeframe: 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycleIntegration of concentration of 14C-BaP in plasma over time. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine AUC.
Outcome measures
| Measure |
50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose
n=7 Participants
Cycle 1: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Subjects will consume 50 g (about 1/2 cup) of lightly steamed Brussels sprouts each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 3: Subjects will consume 300 mg DIM supplement ( 2 capsules of BioResponse DIM® 150) each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP). A 300 mg DIM dose will be co-administrated with the 50 ng BaP dose.
At least 3 weeks will pass between cycles as a washout period.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
Brussels sprouts before 50 ng dose: Brussels sprouts for 7 days before 50 ng (5.4 nCi) dose of BaP
DIM supplement before 50 ng dose: DIM supplement for 7 days before 50 ng (5.4 nCi) dose of BaP and coadministration with DIM supplement
|
|---|---|
|
Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC
50 ng [14C] BaP
|
10.93 fg [14C]-BaP/mL plasma x hour
Standard Deviation 9.19
|
|
Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC
Brussels sprouts before 50 ng [14C] BaP
|
9.34 fg [14C]-BaP/mL plasma x hour
Standard Deviation 10.02
|
|
Area Under Plasma Concentration of 14C-BaP Versus Time Curve AUC
DIM supplement before 50 ng [14C] BaP
|
5.51 fg [14C]-BaP/mL plasma x hour
Standard Deviation 6.17
|
SECONDARY outcome
Timeframe: 0-48 hours for each of 3 dosing cycles, with a washout period of 3 weeks between each dosing cycleDetermination of constants for rate of elimination of 14C-BaP from plasma. Blood samples collected at 0 (baseline), 0.25, 0.5, 1, 2, 3, 4, 8, 24, and 48 hour after dosing. All time points were used to determine half-life.
Outcome measures
| Measure |
50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose
n=7 Participants
Cycle 1: Capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 2: Subjects will consume 50 g (about 1/2 cup) of lightly steamed Brussels sprouts each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP).
Cycle 3: Subjects will consume 300 mg DIM supplement ( 2 capsules of BioResponse DIM® 150) each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) \[14C\]-benzo\[a\]pyrene (BaP). A 300 mg DIM dose will be co-administrated with the 50 ng BaP dose.
At least 3 weeks will pass between cycles as a washout period.
\[14C\]-benzo\[a\]pyrene: Oral micro-dose (50 ng) (5.4 nCi)
Brussels sprouts before 50 ng dose: Brussels sprouts for 7 days before 50 ng (5.4 nCi) dose of BaP
DIM supplement before 50 ng dose: DIM supplement for 7 days before 50 ng (5.4 nCi) dose of BaP and coadministration with DIM supplement
|
|---|---|
|
Rate of Elimination of 14C-BaP (Half Life)
50 ng [14C] BaP
|
3.69 hour
Standard Deviation 3.80
|
|
Rate of Elimination of 14C-BaP (Half Life)
Brussels sprouts before 50 ng [14C] BaP
|
3.86 hour
Standard Deviation 4.62
|
|
Rate of Elimination of 14C-BaP (Half Life)
DIM supplement before 50 ng [14C] BaP
|
9.75 hour
Standard Deviation 13.25
|
Adverse Events
50 ng Dose; Brussels Sprouts Before 50 ng Dose; DIM Supplement Before 50 ng Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place