Cross-Over Broccoli Sprouts Trial

Cross-Over Broccoli Sprouts Trial - Qidong

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01008826

Enrollment

Registered

2009-11-06

Start date

2009-10-31

Completion date

2009-12-31

Last updated

2011-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

sulforaphane, pharmacokinetics

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

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

* 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.

Design outcomes

Primary

Measure	Time frame
Urinary levels of glucoraphanin or sulforaphane and metabolites.	Endpoints will be assessed on urine samples collected daily during the intervention.

Secondary

Measure	Time frame
Urinary levels of aflatoxin-DNA adducts and mercapturic acids as well as mercapturic acids of air-borne pollutants	Endpoints will be assessed on urine samples collected daily during the intervention.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026