Phase 2
N=170
Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants
Environmental Carcinogenesis
Bottom Line
View on ClinicalTrials.gov: NCT02656420 ↗Enrolled (actual)
170
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples — 24.8; 11.0; 4.3 micromoles/24 hours — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Broccoli Sprout-derived Beverage (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples |
24.8; 11.0; 4.3 | <0.001 sig |
| SECONDARY Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples |
0.67; 0.62; 0.74; 1.09 | <0.05 sig |
Summary
This study will examine the extent to which lower doses of a broccoli-derived beverage enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose shown to be effective previously.
Eligibility Criteria
Inclusion Criteria
- in good general health with no history of chronic illness
- normal liver function tests
- normal renal function tests
Exclusion Criteria
- personal history of cancer except for non-melanoma skin cancer
- use of prescribed medicines
- for women, a positive pregnancy test
Data sourced from ClinicalTrials.gov (NCT02656420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.