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Completed

NCT Number: NCT03399656

Broccoli Supplement Dose Response

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.

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Key information

Conditions

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qidong Liver Cancer Institute

Qidong, Jiangsu, 226200, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avmacol tablets

Dietary Supplement

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.

Placebo tablets

Dietary Supplement

MCC 90M Emcocel

Primary outcomes

  1. Excretion of sulforaphane and metabolites in urine

    Time frame: Consecutive overnight urine samples collected for the duration of the study (21 days)

    Levels of sulforaphane and its glutathione-conjugate derived metabolites will be measured in consecutive overnight urine samples

Secondary outcomes

  1. Air pollution biomarkers in urine

    Time frame: Consecutive overnight urine samples collected for the duration of the study (21 days)

    Levels of benzene mercapturic acid excreted in urine

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Qidong Liver Cancer Institute

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2018
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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