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Completed

NCT Number: NCT01437501

Broccoli Sprout Intervention in Qidong, P.R. China

This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships will be screened and three hundred eligible individuals will be enrolled in the study. Participants will be randomized into two treatment groups: one will receive a juice beverage containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice, lime juice, and water and the other will receive a placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide biweekly urine samples and monthly blood samples. The principal endpoints of this study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of exposure biomarkers for dietary and air-borne toxins, which are known to be high in this population.

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Key information

Conditions

Environmental Carcinogenesis

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

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

  • age 21-65 years
  • in good general health with no history of chronic illness
  • normal liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin)
  • normal renal function tests (creatinine, blood urea nitrogen, 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
  • for women, a positive pregnancy test

Treatment and study plan

Broccoli Sprout Extract Beverage

Drug

Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.

Placebo Beverage

Drug

100 mL of dilute pineapple and lime juice daily for 84 days.

Primary outcomes

  1. Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period

    Time frame: Endpoints were assessed on urine samples collected at the end of the intervention on week 12.

    Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks

Secondary outcomes

  1. Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)

    Time frame: Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])

    Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Johns Hopkins University
  • National Institute of Environmental Health Sciences (NIEHS)
  • Qidong Liver Cancer Institute
  • University of Minnesota
  • University of Pittsburgh

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 21, 2011
Registry last updated
Aug 16, 2018

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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