Broccoli Supplement Dose Response

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Broccoli Supplement Dose Response

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Avmacol tablets
* Dietary Supplement: Placebo tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 21 and ≤ 70 years who are residents of Qidong, China. Able to provide written, informed consent. Normal physical examination and medical history indicative of good general health with no history of chronic illness. No hepatomegaly by clinical exam; Normal liver function tests (ALT, aspartate aminotransferase (AST), bilirubin); Normal renal function tests (creatinine, blood urea nitrogen (BUN), urinalysis); Serum alpha-fetoprotein (AFP) negative. Exclusion Criteria: Pregnant (positive human chorionic gonadotropin (HCG) strip test) Current or former diagnosis of cancer, with the exception of non-melanomatous skin cancer.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>4 placebo tablets | Dietary Supplement: Placebo tablets<br>* MCC 90M Emcocel<br>|
| Active Comparator: Low Dose Avmacol<br>2 tablets Avmacol and 2 placebo tablets | Dietary Supplement: Avmacol tablets<br>* 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.<br>Dietary Supplement: Placebo tablets<br>* MCC 90M Emcocel<br>|
| Active Comparator: High Dose Avmacol<br>4 Avmacol tablets | Dietary Supplement: Avmacol tablets<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excretion of sulforaphane and metabolites in urine | Levels of sulforaphane and its glutathione-conjugate derived metabolites will be measured in consecutive overnight urine samples | Consecutive overnight urine samples collected for the duration of the study (21 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air pollution biomarkers in urine | Levels of benzene mercapturic acid excreted in urine | Consecutive overnight urine samples collected for the duration of the study (21 days) |