Environmental CarcinogenesisPhase 2NCT01437501

Broccoli Sprout Intervention in Qidong, P.R. China

A Phase 2 study testing Broccoli Sprout Extract Beverage in people with Environmental Carcinogenesis, run by Johns Hopkins Bloomberg School of Public Health at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Environmental Carcinogenesis
What is being tested?: Broccoli Sprout Extract Beverage
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 291 participants
Where: 1 siteChina
Study dates: Oct 2011to Jan 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

personal history of cancer except for non-melanoma skin cancer
use of prescribed medications
hepatomegaly by clinical exam
for women, a positive pregnancy test

Trial locations and contacts

1 site in 1 country.

China1 site

Qidong Liver Cancer Institute
Qidong, Jiangsu, 226200

Other trials in China

About this study

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.

Conditions: Environmental Carcinogenesis
Being tested: Broccoli Sprout Extract Beverage, placebo beverage
Keywords: glucoraphanin, sulforaphane, pharmacokinetics, pharmacodynamics, broccoli sprout, carcinogens, environment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Broccoli Sprout Extract BeverageDrug
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 beverageDrug
100 mL of dilute pineapple and lime juice daily for 84 days.

Study groups in NCT01437501
Study group	Role	What they receive
Broccoli Sprout Extract Beverage	Experimental	Not described Receives: Drug: Broccoli Sprout Extract Beverage
Placebo beverage	Placebo comparator	Not described Receives: Drug: placebo beverage

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Jan 2012

First posted21 Sep 2011 (estimated)
Study startOct 2011
Primary completionJan 2012
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Environmental CarcinogenesisStudies of the same condition, open and under way.
More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 291 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01437501
Sponsor's protocol ID: IRB00003494
Other IDs: 5P01ES006052
Status last verified: Jul 2018
First submitted: 15 Sep 2011
Last updated: 16 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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. doi: 10.1158/1055-9965.EPI-05-0368.
PubMed 16284385
Egner PA, Chen JG, Wang JB, Wu Y, Sun Y, Lu JH, Zhu J, Zhang YH, Chen YS, Friesen MD, Jacobson LP, Munoz 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.
PubMed 21372038

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Broccoli Sprout Intervention in Qidong, P.R. China
ClinicalTrials.gov ID: NCT01437501
Acronym / sponsor ID: IRB00003494
Conditions: Environmental Carcinogenesis
Keywords: glucoraphanin, sulforaphane, pharmacokinetics, pharmacodynamics, broccoli sprout, carcinogens, environment
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 291 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Collaborators: Johns Hopkins University, National Institute of Environmental Health Sciences (NIEHS), Qidong Liver Cancer Institute, University of Pittsburgh, University of Minnesota
Study start: Oct 2011
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 21 Sep 2011 (estimated)
Results: Posted 23 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Broccoli Sprout Extract Beverage	Experimental	Drug: Broccoli Sprout Extract Beverage
Placebo beverage	Placebo comparator	Drug: placebo beverage

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

personal history of cancer except for non-melanoma skin cancer
use of prescribed medications
hepatomegaly by clinical exam
for women, a positive pregnancy test

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Broccoli Sprout Extract BeverageBroccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.	Drug	Broccoli Sprout Extract Beverage
placebo beverage100 mL of dilute pineapple and lime juice daily for 84 days.	Drug	Placebo beverage

Primary outcome

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

1 secondary outcome

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

Results and safety

Results posted to the registry on 23 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Broccoli Sprout Extract Beverage	148	135
Placebo Beverage	143	132

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

Time frame: Endpoints were assessed on urine samples collected at the end of the intervention on week 12.. Median (Inter-Quartile Range). Unit: pmol/mg creatinine

Measure	Broccoli Sprout Extract Beverage n = 135	Placebo Beverage n = 132
Value	1.700 (1.235 to 2.386)	1.065 (0.686 to 1.826)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0.3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Broccoli Sprout Extract Beverage	0 of 148 (0%)	6 of 148 (4.1%)	Not reported
Placebo Beverage	0 of 143 (0%)	4 of 143 (2.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16284385Kensler 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. doi: 10.1158/1055-9965.EPI-05-0368.
Background: PubMed 21372038Egner PA, Chen JG, Wang JB, Wu Y, Sun Y, Lu JH, Zhu J, Zhang YH, Chen YS, Friesen MD, Jacobson LP, Munoz 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas W Kensler, PhD principal investigator

Johns Hopkins Bloomberg School of Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Broccoli Sprout Extract Beverage in people with Environmental Carcinogenesis, run by Johns Hopkins Bloomberg School of Public Health at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period (time frame: Endpoints were assessed on urine samples collected at the end of the intervention on week 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01437501, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.