Environmental CarcinogenesisPhase 1/2NCT02656420
Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants
A Phase 1/2 study testing Broccoli Sprout-derived Beverage in people with Environmental Carcinogenesis, run by Johns Hopkins Bloomberg School of Public Health at 1 site in China.
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. Read more about this study
- 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-derived Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Mar 2016
- Phase
- Phase 1/2
- 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
- in good general health with no history of chronic illness
- normal liver function tests
- normal renal function tests
Who cannot join
- personal history of cancer except for non-melanoma skin cancer
- use of prescribed medicines
- for women, a positive pregnancy test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Broccoli Sprout Dose Response: Bioavailability and Effects on Air Pollutants
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.
Read the 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.
- Conditions
- Environmental Carcinogenesis
- Being tested
- Broccoli Sprout-derived Beverage, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli Sprout-derived BeverageDrug
Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.
PlacebosDrug
Placebo as comparison to broccoli sprout-derived beverages
| Study group | Role | What they receive |
|---|---|---|
| Placebos | Placebo comparator | Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days. Receives: Drug: Placebos |
| High Dose Broccoli Sprout | Experimental | 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. Receives: Drug: Broccoli Sprout-derived Beverage |
| Medium Dose Broccoli Sprout | Experimental | 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. Receives: Drug: Broccoli Sprout-derived Beverage |
| Low Dose Broccoli Sprout | Experimental | 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. Receives: Drug: Broccoli Sprout-derived Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary outcomes (1)
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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionMar 2016
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Qidong Liver Cancer Institute, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas Kensler, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656420
- Sponsor's protocol ID
- IRB00006734
- Other IDs
- R01CA190610
- Status last verified
- Apr 2019
- First submitted
- 5 Jan 2016
- Last updated
- 1 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24913818Chen 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.
PubMed 31268126
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Broccoli Sprout Dose Response: Bioavailability and Effects on Air Pollutants
- ClinicalTrials.gov ID
- NCT02656420
- Acronym / sponsor ID
- IRB00006734
- Conditions
- Environmental Carcinogenesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Qidong Liver Cancer Institute, National Cancer Institute (NCI)
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Posted 1 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebos | Placebo comparator | Drug: PlacebosBeverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days. |
| High Dose Broccoli Sprout | Experimental | Drug: Broccoli Sprout-derived BeverageBeverage (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. |
| Medium Dose Broccoli Sprout | Experimental | Drug: Broccoli Sprout-derived BeverageBeverage (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. |
| Low Dose Broccoli Sprout | Experimental | Drug: Broccoli Sprout-derived BeverageBeverage (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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- in good general health with no history of chronic illness
- normal liver function tests
- normal renal function tests
Key exclusion criteria (3 listed)
- personal history of cancer except for non-melanoma skin cancer
- use of prescribed medicines
- 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-derived BeverageMaximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos. | Drug | High Dose Broccoli Sprout, Low Dose Broccoli Sprout, Medium Dose Broccoli Sprout |
| PlacebosPlacebo as comparison to broccoli sprout-derived beverages | Drug | Placebos |
Primary outcome
Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples
Time frame: 10 days
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.
1 secondary outcome
Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24913818Egner 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.
- Derived from this study: PubMed 31268126Chen 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.
- Individual participant dataSharing planned: No
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 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 1/2 study testing Broccoli Sprout-derived 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 3 inclusion and 3 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 1 May 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 1 May 2019). 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?
Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples (time frame: 10 days). 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 NCT02656420, 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 1 May 2019.