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Sulforaphane

Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.

Broccoli Sprout Extract Beverage

100 mL of dilute pineapple and lime juice daily for 84 days.

placebo beverage

Thomas W Kensler, PhD

This study is a 12 week placebo-controlled Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. One thousand two hundred people from the farming townships will be screened and three hundred eligible individuals will be enrolled in the study. Participants will be randomized into two treatment groups: one will receive a juice beverage containing glucoraphanin- and sulforaphane-rich broccoli sprout extract, pineapple juice, lime juice, and water and the other will receive a placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide biweekly urine samples and monthly blood samples. The principal endpoints of this study are pharmacokinetic evaluation of elimination of glucoraphanin/sulforaphane and their metabolites in urine and pharmacodynamic evaluation through measures of urinary levels of exposure biomarkers for dietary and air-borne toxins, which are known to be high in this population.

Broccoli Sprout Intervention in Qidong, P.R. China

Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks

Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.

Johns Hopkins University

National Institute of Environmental Health Sciences (NIEHS)

Qidong Liver Cancer Institute

University of Pittsburgh

University of Minnesota

Johns Hopkins Bloomberg School of Public Health

Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.

placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.

Placebo Beverage

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

China

Region of Enrollment

Thomas W. Kensler, PhD

Analyses were conducted on all urine samples provided by study participants at week 12.

Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period

placebo beverage: 100 mL of dilute pineapple and lime juice daily for 84 days.

Broccoli Sprout Extract Beverage: Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.

Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)

Overall Study

Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.

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.

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.

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.

Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.

Broccoli Sprout-derived Beverage

Placebo as comparison to broccoli sprout-derived beverages

Placebos

Thomas Kensler, PhD

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.

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.

Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

Broccoli Sprout Dose Response: Bioavailability and Effects on Air Pollutants

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.

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.

National Cancer Institute (NCI)

Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.

Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.

Placebo

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.

Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.

High Dose Broccoli Sprout

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.

Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.

Medium Dose Broccoli Sprout

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.

Broccoli Sprout Powder: Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebo.

Low Dose Broccoli Sprout

Dr. Thomas W. Kensler

The null hypothesis is that the urinary sulforaphane levels are equal across treatment arms. Sulforaphane metabolite levels were measured daily for 10 days in each arm.

Placebo arm samples were not analyzed f because no sulforaphane was administered to this group. Historically, background levels from dietary sources in this population are very low compared to active intervention levels. In addition, one participant in the High Dose Broccoli Sprout arm did not complete the full protocol and was not included.

Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples

All broccoli sprout arms were compared with the placebo arm.

Due to irreversible failure of the mass spectrometer used in this analysis, not all urine samples were evaluated for SPMA levels. Only individuals for whom all 10 samples were collected and analyzed are included in this summary (132/169).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Broccoli Sprout Intervention in Qidong, P.R. China	NCT01437501	Environmental C...	Broccoli Sprout... placebo beverag...	21 Years - 65 Years	Johns Hopkins Bloomberg School of Public Health
Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants	NCT02656420	Environmental C...	Broccoli Sprout... Placebos	21 Years - 65 Years	Johns Hopkins Bloomberg School of Public Health
Broccoli Sprout Intervention in Qidong, P.R. China	NCT01437501	Environmental C...	Broccoli Sprout... placebo beverag...	21 Years - 65 Years	Johns Hopkins Bloomberg School of Public Health
Broccoli Sprout Intervention in Qidong, P.R. China	NCT01437501	Environmental C...	Broccoli Sprout... placebo beverag...	21 Years - 65 Years	Johns Hopkins Bloomberg School of Public Health

Spots Global Cancer Trial Database for environmental carcinogenesis