Clinical Trial: Broccoli Sprout Intervention in Qidong, P.R. China

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Broccoli Sprout Intervention in Qidong, P.R. China

Brief Summary: 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.

Detailed Summary:
Sponsor: Johns Hopkins Bloomberg School of Public Health

Current Primary Outcome: 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


Original Primary Outcome:

  • Change from baseline in Aflatoxin-DNA Adduct biomarkers over intervention period [ Time Frame: Endpoints will be assessed on urine and blood samples collected during the intervention on weeks 0, 1, 2, 4, 6, 8, 10 and 12. ]
    Urinary levels of aflatoxin-DNA adducts.
  • Change from baseline in Aflatoxin mercapturic acids over intervention period [ Time Frame: Endpoints will be assessed on urine and blood samples collected during the intervention on weeks 0, 1, 2, 4, 6, 8, 10 and 12. ]
  • Change from baseline in air toxics mercapturic acids over intervention period [ Time Frame: Endpoints will be assessed on urine and blood samples collected during the intervention on weeks 0, 1, 2, 4, 6, 8, 10 and 12. ]


Current Secondary Outcome: Change From Baseline in Levels of Glucoraphanin/Sulforaphane and Their Metabolites Over Intervention Period [ Time Frame: Endpoints assessed on urine and blood samples collected during the intervention on weeks 0, 1, 2, 4, 6, 8, 10 and 12. ]

Original Secondary Outcome: Change From Baseline in Levels of Glucoraphanin/Sulforaphane and Their Metabolites Over Intervention Period [ Time Frame: Endpoints will be assessed on urine and blood samples collected during the intervention on weeks 0, 1, 2, 4, 6, 8, 10 and 12. ]

Information By: Johns Hopkins Bloomberg School of Public Health

Dates:
Date Received: September 15, 2011
Date Started: October 2011
Date Completion:
Last Updated: September 19, 2013
Last Verified: September 2013