Broccoli Sprout Intervention in Qidong, P.R. China

• Sponsor: Johns Hopkins Bloomberg School of Public Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01437501
• Collaborator: Johns Hopkins University (Other), National Institute of Environmental Health Sciences (NIEHS) (NIH), Qidong Liver Cancer Institute (Other), University of Pittsburgh (Other), University of Minnesota (Other)
• Enrollment: 291
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 96.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Environmental Carcinogenesis	Drug: Broccoli Sprout Extract Beverage; Drug: placebo beverage	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 291 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Broccoli Sprout Intervention in Qidong, P.R. China
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Broccoli Sprout Extract Beverage	Drug: 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 Comparator: Placebo beverage	Drug: placebo beverage; 100 mL of dilute pineapple and lime juice daily for 84 days.

Outcome Measures

Primary Outcome Measures

1. Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period [Endpoints were assessed on urine samples collected at the end of the intervention on week 12.]

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

Secondary Outcome Measures

1. Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses) [Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age 21-65 years

• in good general health with no history of chronic illness

• normal liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin)

• normal renal function tests (creatinine, blood urea nitrogen, urinalysis)

• serum alpha-fetoprotein negative

Exclusion Criteria:

• personal history of cancer except for non-melanoma skin cancer

• use of prescribed medications

• hepatomegaly by clinical exam

• for women, a positive pregnancy test

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qidong Liver Cancer Institute	Qidong	Jiangsu	China	226200

Sponsors and Collaborators

• Johns Hopkins Bloomberg School of Public Health
• Johns Hopkins University
• National Institute of Environmental Health Sciences (NIEHS)
• Qidong Liver Cancer Institute
• University of Pittsburgh
• University of Minnesota

Investigators

• Principal Investigator: Thomas W Kensler, PhD, Johns Hopkins Bloomberg School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

• Egner PA, Chen JG, Wang JB, Wu Y, Sun Y, Lu JH, Zhu J, Zhang YH, Chen YS, Friesen MD, Jacobson LP, Muñoz A, Ng D, Qian GS, Zhu YR, Chen TY, Botting NP, Zhang Q, Fahey JW, Talalay P, Groopman JD, Kensler TW. Bioavailability of Sulforaphane from two broccoli sprout beverages: results of a short-term, cross-over clinical trial in Qidong, China. Cancer Prev Res (Phila). 2011 Mar;4(3):384-95. doi: 10.1158/1940-6207.CAPR-10-0296.
• Kensler TW, Chen JG, Egner PA, Fahey JW, Jacobson LP, Stephenson KK, Ye L, Coady JL, Wang JB, Wu Y, Sun Y, Zhang QN, Zhang BC, Zhu YR, Qian GS, Carmella SG, Hecht SS, Benning L, Gange SJ, Groopman JD, Talalay P. Effects of glucosinolate-rich broccoli sprouts on urinary levels of aflatoxin-DNA adducts and phenanthrene tetraols in a randomized clinical trial in He Zuo township, Qidong, People's Republic of China. Cancer Epidemiol Biomarkers Prev. 2005 Nov;14(11 Pt 1):2605-13.

• Responsible Party: Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT01437501
• Other Study ID Numbers: IRB00003494; 5P01ES006052
• First Posted: Sep 21, 2011
• Last Update Posted: Aug 16, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by Johns Hopkins Bloomberg School of Public Health: glucoraphanin; sulforaphane; pharmacokinetics; pharmacodynamics; broccoli sprout; carcinogens, environment
• Additional relevant MeSH terms: Carcinogenesis

Study Results

Participant Flow

Recruitment Details	1205 Individuals were recruited from HeHe Township in Qidong, PRC for eligibility screening at 3 medical clinics within the township in September 2011.

Arm/Group Title	Broccoli Sprout Extract Beverage	Placebo Beverage
Arm/Group Description	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.
Period Title: Overall Study
STARTED	148	143
COMPLETED	135	132
NOT COMPLETED	13	11

Baseline Characteristics

Arm/Group Title	Broccoli Sprout Extract Beverage	Placebo Beverage	Total
Arm/Group Description	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.	Total of all reporting groups
Overall Participants	148	143	291
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	148 100%	143 100%	291 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.1 (9.4)	52.6 (7.7)	51.8 (8.7)
Sex: Female, Male (Count of Participants)
Female	118 79.7%	111 77.6%	229 78.7%
Male	30 20.3%	32 22.4%	62 21.3%
Region of Enrollment (participants) [Number]
China	148 100%	143 100%	291 100%

Outcome Measures

1. Primary Outcome

Title	Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period
Description	Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks
Time Frame	Endpoints were assessed on urine samples collected at the end of the intervention on week 12.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Broccoli Sprout Extract Beverage	Placebo Beverage
Arm/Group Description	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.
Measure Participants	135	132
Median (Inter-Quartile Range) [pmol/mg creatinine]	1.700	1.065

2. Secondary Outcome

Title	Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)
Description	Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.
Time Frame	Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Beverage	Broccoli Sprout Extract Beverage
Arm/Group Description	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.
Measure Participants	132	135
Median (Inter-Quartile Range) [micromoles]	1	62

Adverse Events

Time Frame	3 months
Arm/Group Title	Broccoli Sprout Extract Beverage		Placebo Beverage
Arm/Group Description	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.
All Cause Mortality
	Broccoli Sprout Extract Beverage		Placebo Beverage
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Broccoli Sprout Extract Beverage		Placebo Beverage
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/148 (0%)		0/143 (0%)
Other (Not Including Serious) Adverse Events
	Broccoli Sprout Extract Beverage		Placebo Beverage
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/148 (4.1%)		4/143 (2.8%)
Gastrointestinal disorders
light vomiting	1/148 (0.7%)	1	0/143 (0%)	0
indigestion	4/148 (2.7%)	4	2/143 (1.4%)	2
taste	1/148 (0.7%)	1	2/143 (1.4%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.