Clinical trial NCT02656420: Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants
Official title: Broccoli Sprout Dose Response: Bioavailability and Effects on Air Pollutants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Environmental Carcinogenesis
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Qidong Liver Cancer Institute
name: National Cancer Institute (NCI)
First posted: 2016-01-15
Enrollment: 170
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples
timeFrame: 10 days
Secondary outcomes:
measure: Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples
timeFrame: 10 days
Other outcomes:
Locations:
city: Qidong
country: China
facility: Qidong Liver Cancer Institute
state: Jiangsu
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Thomas Kensler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Egner PA, Chen JG, Zarth AT, Ng DK, Wang JB, Kensler KH, Jacobson LP, Munoz A, Johnson JL, Groopman JD, Fahey JW, Talalay P, Zhu J, Chen TY, Qian GS, Carmella SG, Hecht SS, Kensler TW. Rapid and sustainable detoxication of airborne pollutants by broccoli sprout beverage: results of a randomized clinical trial in China. Cancer Prev Res (Phila). 2014 Aug;7(8):813-823. doi: 10.1158/1940-6207.CAPR-14-0103. Epub 2014 Jun 9.
citation: Chen JG, Johnson J, Egner P, Ng D, Zhu J, Wang JB, Xue XF, Sun Y, Zhang YH, Lu LL, Chen YS, Wu Y, Zhu YR, Carmella S, Hecht S, Jacobson L, Munoz A, Kensler K, Rule A, Fahey J, Kensler T, Groopman J. Dose-dependent detoxication of the airborne pollutant benzene in a randomized trial of broccoli sprout beverage in Qidong, China. Am J Clin Nutr. 2019 Sep 1;110(3):675-684. doi: 10.1093/ajcn/nqz122.