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CompletedNCT01008826Updated Sep 16, 2011

Cross-Over Broccoli Sprouts Trial

A Phase 1 interventional study of broccoli sprouts extract in Healthy, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in China. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-16.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy

Keywords

  • sulforaphane
  • pharmacokinetics
03

In context

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    glucoraphanin-rich broccoli extract

    Dietary Supplement: broccoli sprouts extract

  • Experimental
    sulforaphane-rich broccoli extract

    Dietary Supplement: broccoli sprouts extract

Interventions

  • Dietary supplementbroccoli sprouts extract

    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

06

What researchers measure

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.

07

Study locations

1 site
  • Qidong Liver Cancer Institute
    Qidong, Jiangsu 226200, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01008826
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Qidong Liver Cancer Institute
Responsible party
Thomas Kensler (Professor, Johns Hopkins Bloomberg School of Public Health) — Principal investigator
First posted
Nov 6, 2009
Start date
Oct 2009
Primary completion
Nov 2009
Completion
Dec 2009
Last update
Sep 16, 2011

Study contacts

Thomas W Kensler, PhD
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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