Trial Outcomes & Findings for Broccoli Sprout/Broccoli Seed Extract Supplement in Decreasing Toxicity in Heavy Smokers (NCT NCT03402230)
NCT ID: NCT03402230
Last Updated: 2023-06-28
Results Overview
Change in the overnight urinary excretion the mercapturic acid of benzene following 4 tablets per day of Avmacol. Data presented as ratio of the geometric mean of overnight urinary excretion the mercapturic acid of benzene between post intervention and baseline.
COMPLETED
EARLY_PHASE1
49 participants
Baseline up to 14 days post intervention
2023-06-28
Participant Flow
Participant milestones
| Measure |
Avmacol Low Dose First, Then High Dose
Participants received lower dose of Avmacol daily for 10-14 days, followed by 10-14 days of washout, and followed by higher dose of Avmacol daily for 10-14 days.
|
Avmacol High Dose First, Then Low Dose
Participants received higher dose of Avmacol daily for 10-14 days, followed by 10-14 days of washout, and followed by lower dose of Avmacol daily for 10-14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Broccoli Sprout/Broccoli Seed Extract Supplement in Decreasing Toxicity in Heavy Smokers
Baseline characteristics by cohort
| Measure |
Avmacol
n=49 Participants
Participants who initiated Avmacol intervention
|
|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 14 days post interventionChange in the overnight urinary excretion the mercapturic acid of benzene following 4 tablets per day of Avmacol. Data presented as ratio of the geometric mean of overnight urinary excretion the mercapturic acid of benzene between post intervention and baseline.
Outcome measures
| Measure |
Avmacol
n=48 Participants
Participants who initiated Avmacol intervention
|
Avmacol 8 Tablets
Participants received 8 tablets of the study agent PO daily for 10-14 days.
Broccoli Sprout/Broccoli Seed Extract Supplement: Given PO
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Urinary Excretion of the Mercapturic Acid of Benzene Following 4 Tablets Per Day of Avmacol
|
1.16 data presented as ratio; no unit
Interval 0.998 to 1.344
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 14 days post interventionChange in the overnight urinary excretion the mercapturic acid of benzene following 8 tablets per day of Avmacol. Data presented as ratio of the geometric mean of overnight urinary excretion the mercapturic acid of benzene between post intervention and baseline.
Outcome measures
| Measure |
Avmacol
n=48 Participants
Participants who initiated Avmacol intervention
|
Avmacol 8 Tablets
Participants received 8 tablets of the study agent PO daily for 10-14 days.
Broccoli Sprout/Broccoli Seed Extract Supplement: Given PO
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Urinary Excretion of the Mercapturic Acid of Benzene Following 8 Tablets Per Day of Avmacol
|
1.19 data presented as ratio; no unit
Interval 1.005 to 1.409
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 14 days post interventionChange following 4 tablets per day and 8 tablets per day of Avmacol wad determined separately. Data presented as ratio of the geometric mean of overnight urinary excretion of the mercapturic acid of acrolein/crotonaldehyde between post intervention and baseline.
Outcome measures
| Measure |
Avmacol
n=48 Participants
Participants who initiated Avmacol intervention
|
Avmacol 8 Tablets
n=48 Participants
Participants received 8 tablets of the study agent PO daily for 10-14 days.
Broccoli Sprout/Broccoli Seed Extract Supplement: Given PO
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in the Urinary Excretion of the Mercapturic Acids of Acrolein and Crotonaldehyde
Urindary excretion of mercapturic acid of acrolein
|
1.11 data presented as ratio; no unit
Interval 0.98 to 1.26
|
1.28 data presented as ratio; no unit
Interval 1.06 to 1.53
|
|
Change in the Urinary Excretion of the Mercapturic Acids of Acrolein and Crotonaldehyde
Urinary excretion of mercapturic acid of crotonaldehyde
|
1.05 data presented as ratio; no unit
Interval 0.9 to 1.22
|
1.18 data presented as ratio; no unit
Interval 1.02 to 1.37
|
SECONDARY outcome
Timeframe: Baseline up to 14 days post interventionChange in the expression of NQO1 in the buccal cells after 8 tablets per day of Avmacol. Data presented as ratio of the geometric mean of the gene expression of NQO1 between post intervention and baseline.
Outcome measures
| Measure |
Avmacol
n=48 Participants
Participants who initiated Avmacol intervention
|
Avmacol 8 Tablets
Participants received 8 tablets of the study agent PO daily for 10-14 days.
Broccoli Sprout/Broccoli Seed Extract Supplement: Given PO
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in the NRF2 Target Gene Transcripts
|
1.00 data presented as ratio; no unit
Interval 0.98 to 1.02
|
—
|
SECONDARY outcome
Timeframe: Up to 14 days post interventionDose-response relationship between the Avmacol dose and the detoxification of tobacco carcinogens. Data presented as ratio of percent change of the overnight urinary excretion of mercapturic acid of benzene/acrolein/crotonaldehyde between the 8 tables and 4 tables dose.
Outcome measures
| Measure |
Avmacol
n=48 Participants
Participants who initiated Avmacol intervention
|
Avmacol 8 Tablets
Participants received 8 tablets of the study agent PO daily for 10-14 days.
Broccoli Sprout/Broccoli Seed Extract Supplement: Given PO
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Dose-response Relationship Between Avmacol Dose and Detoxification of Tobacco Carcinogens
Mercapturic acid of acrolein
|
1.14 data presented as ratio; no unit
Interval 0.95 to 1.36
|
—
|
|
Dose-response Relationship Between Avmacol Dose and Detoxification of Tobacco Carcinogens
Mercapturic acid of crotonaldehyde
|
1.12 data presented as ratio; no unit
Interval 0.95 to 1.32
|
—
|
|
Dose-response Relationship Between Avmacol Dose and Detoxification of Tobacco Carcinogens
Mercapturic acid of benzene
|
1.01 data presented as ratio; no unit
Interval 0.89 to 1.15
|
—
|
SECONDARY outcome
Timeframe: Up to 14 days post interventionChange in the total urinary levels of sulforaphane and its glutathione-derived metabolites (i.e., the sum of the molar concentrations of sulforaphane and its glutathione-derived metabolites in urine). Data presented as ratio of the geometric mean of the total urinary levels of sulforaphane and its metabolites between post intervention and baseline.
Outcome measures
| Measure |
Avmacol
n=48 Participants
Participants who initiated Avmacol intervention
|
Avmacol 8 Tablets
n=48 Participants
Participants received 8 tablets of the study agent PO daily for 10-14 days.
Broccoli Sprout/Broccoli Seed Extract Supplement: Given PO
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Systemic Study Agent Exposure
|
467.9 data presented as ratio; no unit
Interval 264.7 to 826.9
|
990.0 data presented as ratio; no unit
Interval 592.2 to 1655.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 14 days post interventionPopulation: The data were presented by genotype. Therefore, the number of participants with a particular genotype is a subset of the overall number of participants analyzed.
Change in the urinary excretion of the mercapturic acids of tobacco carcinogens by GSTM1 and GSTT1 genotype. Data presented as ratio of the geometric mean of urinary excretion of mercapturic acid of benzene between post intervention and baseline for each genotype.
Outcome measures
| Measure |
Avmacol
n=48 Participants
Participants who initiated Avmacol intervention
|
Avmacol 8 Tablets
n=48 Participants
Participants received 8 tablets of the study agent PO daily for 10-14 days.
Broccoli Sprout/Broccoli Seed Extract Supplement: Given PO
Laboratory Biomarker Analysis: Correlative studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
GSTM1 and GSTT1 Genotypes
Mercapturic acid of benzene in GSTM1-null participants
|
1.23 data presented as ratio; no unit
Interval 0.99 to 1.52
|
1.34 data presented as ratio; no unit
Interval 0.98 to 1.84
|
|
GSTM1 and GSTT1 Genotypes
Mercapturic acid of benzene in GSTM1-positive participants
|
1.10 data presented as ratio; no unit
Interval 0.9 to 1.35
|
1.06 data presented as ratio; no unit
Interval 0.93 to 1.21
|
|
GSTM1 and GSTT1 Genotypes
Mercapturic acid of benzene in GSTT1-null participants
|
0.75 data presented as ratio; no unit
Interval 0.54 to 1.04
|
1.16 data presented as ratio; no unit
Interval 0.89 to 1.51
|
|
GSTM1 and GSTT1 Genotypes
Mercapturic acid of benzene in GSTT1-positive participants
|
1.26 data presented as ratio; no unit
Interval 1.08 to 1.47
|
1.20 data presented as ratio; no unit
Interval 0.98 to 1.45
|
Adverse Events
High Dose
Low Dose
Serious adverse events
| Measure |
High Dose
n=49 participants at risk
8 Tablets of Broccoli Sprout/Broccoli Seed Extract Per Day for 14 days
|
Low Dose
n=48 participants at risk
4 Tablets of Broccoli Sprout/Broccoli Seed Extract Per Day for 14 days
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/49 • Two weeks of agent intervention
|
0.00%
0/48 • Two weeks of agent intervention
|
Other adverse events
| Measure |
High Dose
n=49 participants at risk
8 Tablets of Broccoli Sprout/Broccoli Seed Extract Per Day for 14 days
|
Low Dose
n=48 participants at risk
4 Tablets of Broccoli Sprout/Broccoli Seed Extract Per Day for 14 days
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
20.4%
10/49 • Two weeks of agent intervention
|
6.2%
3/48 • Two weeks of agent intervention
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
3/49 • Two weeks of agent intervention
|
2.1%
1/48 • Two weeks of agent intervention
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
7/49 • Two weeks of agent intervention
|
6.2%
3/48 • Two weeks of agent intervention
|
|
Gastrointestinal disorders
Gastrointestinal disorders, other
|
18.4%
9/49 • Two weeks of agent intervention
|
14.6%
7/48 • Two weeks of agent intervention
|
|
Gastrointestinal disorders
Abdominal pain
|
20.4%
10/49 • Two weeks of agent intervention
|
2.1%
1/48 • Two weeks of agent intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60