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Completed

NCT Number: NCT01008826

Cross-Over Broccoli Sprouts Trial

The study hypothesis tested is that broccoli sprouts are effective at altering the urinary levels of metabolites of the hepatocarcinogen aflatoxin B1 and of the air-borne pollutant phenanthrene in residents of Qidong, PRC, where exposures are unavoidable and high. The study will evaluate which of two formulations of broccoli sprouts beverage, glucoraphanin-rich or sulforaphane-rich, exhibits the best bioavailability and is most effective at modulating the biomarkers.

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Key information

Conditions

Healthy

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Qidong Liver Cancer Institute

Qidong, Jiangsu, 226200, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults aged 25-65 in good general health with no history of a chronic illness
  • normal liver function tests (ALT, AST, bilirubin)
  • normal renal function tests (creatinine, BUN, urinalysis)
  • serum alpha-fetoprotein negative

Exclusion criteria

  • personal history of cancer, except for non-melanoma skin cancer
  • use of prescribed medications
  • hepatomegaly by clinical exam
  • unwillingness to avoid cruciferous vegetable consumption for the duration of the study
  • for women, a positive pregnancy test.

Treatment and study plan

broccoli sprouts extract

Dietary Supplement

Glucoraphanin-rich broccoli sprouts extract: 800 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice Sulforaphane-rich broccoli sprouts extract: 150 micromoles daily for 7 days dissolved in 100 mL of dilute mango juice

Primary outcomes

  1. Urinary levels of glucoraphanin or sulforaphane and metabolites.

    Time frame: Endpoints will be assessed on urine samples collected daily during the intervention.

Secondary outcomes

  1. Urinary levels of aflatoxin-DNA adducts and mercapturic acids as well as mercapturic acids of air-borne pollutants

    Time frame: Endpoints will be assessed on urine samples collected daily during the intervention.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Qidong Liver Cancer Institute

Registry information

Official study title

Cross-Over Broccoli Sprouts Trial - Qidong

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 6, 2009
Registry last updated
Sep 16, 2011

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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