An interventional study of Avmacol tablets and Placebo tablets in Healthy Volunteers, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in China. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Basic science
Do daily high (4 tablets) or intermediate (2 tablets) administration of the broccoli-based dietary supplement Avmacol® have improved bioavailability over a broccoli sprout beverage rich in sulforaphane and its biogenic precursor, glucoraphanin? The beverage formulation has been used successfully in the investigators' previous intervention studies in regions of China with high levels of air pollution to reduce the body burden of carcinogenic and toxic pollutants. The investigators seek to evaluate a more stable, less expensive formulation of a broccoli sprout preparation that can be used for disease prevention in future studies.
The investigators will conduct a 3-armed placebo-controlled 16-day intervention with the dietary supplement Avmacol® to determine the bioavailability with repeated dosing of a simple tablet-based intervention in the study participants. As shown in Scheme 1, the 3 arms are: 1) 4 tablets of Avmacol® daily for 14 days; 2) 2 tablets of Avmacol® daily for 14 days together with 2 placebo tablets to maintain parity in consumption; and 3) 4 placebo tablets daily for 14 days. In addition, all participants will receive 4 placebo tablets for 2 consecutive run-in days prior to commencing intervention in the 3 distinct arms. Consecutive overnight (12-hour) urine samples will be collected during the 2-day run-in, the 14-day intervention and during a 5-day run-out period (total = 21 days). Additional day-time urine collections will be made at 2 timepoints: the day after administration of Avmacol® tablets begins and the day after the last administration of Avmacol® tablets. A blood sample will be collected at the beginning of the run-in and after the last Avmacol® dose (Day 17 for intervention groups, and for the placebo group) from each participant. The tablets will be taken before dinner each day.
Exclusion Criteria:
4 placebo tablets
Dietary Supplement: Placebo tablets
2 tablets Avmacol and 2 placebo tablets
Dietary Supplement: Avmacol tablets · Dietary Supplement: Placebo tablets
4 Avmacol tablets
Dietary Supplement: Avmacol tablets
The active components of Avmacol® are ground broccoli seeds that provide glucoraphanin and freeze-dried broccoli sprouts that provide a stabilized form of the enzyme myrosinase, which converts glucoraphanin to sulforaphane.
MCC 90M Emcocel
Excretion of sulforaphane and metabolites in urine
Levels of sulforaphane and its glutathione-conjugate derived metabolites will be measured in consecutive overnight urine samples
Time frame: Consecutive overnight urine samples collected for the duration of the study (21 days)
Air pollution biomarkers in urine
Levels of benzene mercapturic acid excreted in urine
Time frame: Consecutive overnight urine samples collected for the duration of the study (21 days)
Plan to share: Yes — Individual participant data (IPD) that underlie results in a publication
Supporting information: Study protocol, Sap, Icf
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Johns Hopkins Bloomberg School of Public Health