Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

Environmental Carcinogenesis Clinical Trial

Official title:

Broccoli Sprout Dose Response: Bioavailability and Effects on Air Pollutants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656420
• Other study ID #: IRB00006734
• Secondary ID: R01CA190610
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2016
• Est. completion date: March 2016

Study information

• Verified date: April 2019
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinogenesis
• Environmental Carcinogenesis

Intervention

Drug:
• Broccoli Sprout-derived Beverage
Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.
• Placebos
Placebo as comparison to broccoli sprout-derived beverages

Locations

Country	Name	City	State
China	Qidong Liver Cancer Institute	Qidong	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Cancer Institute (NCI), Qidong Liver Cancer Institute

Country where clinical trial is conducted

China, 

References & Publications (1)

Egner PA, Chen JG, Zarth AT, Ng DK, Wang JB, Kensler KH, Jacobson LP, Muñoz 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples	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.	10 days
Secondary	Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples	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.	10 days