Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants
- Conditions
- Environmental Carcinogenesis
- Interventions
- Drug: Placebos
- Registration Number
- NCT02656420
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Brief 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.
- Detailed Description
This is a 10-day placebo control Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. Up to twelve hundred people from the farming townships will be screened and one hundred seventy eligible individuals will be enrolled in the study. Participants will be randomized into 4 treatment groups: one will receive a juice beverage containing a standard dose of glucoraphanin- and sulforaphane-rich broccoli sprout powder mixed in pineapple juice, lime juice and water, the second will receive one-half dose, the third one-fifth dose and the fourth group will receive placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide consecutive 12-hour urine collections throughout the duration of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- in good general health with no history of chronic illness
- normal liver function tests
- normal renal function tests
- personal history of cancer except for non-melanoma skin cancer
- use of prescribed medicines
- for women, a positive pregnancy test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low Dose Broccoli Sprout Broccoli Sprout-derived Beverage Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days. High Dose Broccoli Sprout Broccoli Sprout-derived Beverage Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days. Placebos Placebos Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days. Medium Dose Broccoli Sprout Broccoli Sprout-derived Beverage Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.
- Primary Outcome Measures
Name Time Method Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples 10 days Urinary excretion of broccoli-derived sulforaphane metabolites: sulforaphane-mercapturic acid. The metabolites were measured all 20 of the sequential 12-hour urine collections from each participant over the 10-day intervention period. Data from each individual were summed to provide a single "per 24-hours" value for each participant.
- Secondary Outcome Measures
Name Time Method Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples 10 days Benzene-mercapturic acid (SPMA) excretion was measured in the sequential overnight 12-hour urine samples collected across the 10-day study period. Data from each individual were summed and averaged to provide a single "per 12-hours" value for each participant.
Trial Locations
- Locations (1)
Qidong Liver Cancer Institute
🇨🇳Qidong, Jiangsu, China