Healthy SubjectEarly Phase 1BSENCT02023931
Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa
A Early Phase 1 study testing Broccoli Sprout Extract (BSE) in people with Healthy Subject, run by Julie E. Bauman, MD, MPH at 2 sites in United States.
Trial summary
A pilot study has been designed to determine (primary objective) if three brief interventions with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway signaling, including NQO1, GSTs and AKRs, in the oral mucosa of healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Broccoli Sprout Extract (BSE)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Jan 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years. Children will not be recruited into this study because children do not develop head and neck cancer.
- Both males and females are eligible.
- Members of all racial and ethnic groups are eligible.
- Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration (Appendix B).
- No current or former diagnosis of cancer, with the exception of: excised and cured non-melanoma skin cancer; or carcinoma in situ of the cervix
- No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4 (Appendix A)
Show all 16Show fewer
- No chronic anticoagulation
- No chronic use of steroids
- Karnofsky Performance Scale ≥90% (Appendix C)
- Able to provide written, informed consent
- For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention
- No history of food intolerance to broccoli or pineapple and lime juices
- Willing to avoid cruciferous vegetables during the study interventions (Appendix D)
- Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study
- Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study
- Potential effects of Broccoli sprout extract on the developing human fetus: The effects of Broccoli Sprout Extract on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation
Who cannot join
- Failure to meet the above criteria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eye and Ear Institute
Pittsburgh, Pennsylvania, 15213
UPMC Hillman Cancer Center (University of Pittsburgh Cancer Institute)
Pittsburgh, Pennsylvania, 15232
About this study
A pilot study has been designed to determine (primary objective) if three brief interventions with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway signaling, including NQO1, GSTs and AKRs, in the oral mucosa of healthy subjects. Quantitative distribution data and preliminary effect size for specific Nrf2 targets, as measured in serial buccal cell scrapings, will be determined during the course of 3-day exposures to three BSE regimens. These data will inform the design of a randomized, phase II chemoprevention trial in patients with HPV-negative HNSCC.
Ten healthy volunteers will be recruited for this pilot study, Age ≥ 18 years, both male and female: 1) The non-cancer population presenting to the University of Pittsburgh Eye and Ear Institute or the Hillman Cancer Center. This may include patients with benign disease or their friends/family members, or friends/family members of patients with cancer; 2) Professionals, staff, or students at the University of Pittsburgh.
Read the detailed description
Intervention 1, GRR-BSE
If eligible, participants may undergo baseline visit procedures immediately following the screening visit (same day). If necessary for logistical purposes, participants may return for the baseline visit and initiation of the first BSE intervention any time during the 14 days following eligibility assessment. At the baseline visit (day 1), participants will undergo baseline blood and buccal cell collection. Blood collection will be performed by a trained phlebotomist. Buccal cell collection will be conducted by a trained research coordinator, the principal investigator, or a co-investigator. Participants will receive written and verbal instructions and an intervention diary for documentation of the BSE drink, details of the intervention timeline, including overnight voids, blood and buccal cell collection, and days of GRR-BSE consumption. Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention. Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention. For overnight voids, participants will be instructed to begin collecting urine at 5 pm, and to collect all urine through the first morning void on the following day. The intervention diary will have space for participants to record the date and time of each GRR-BSE consumption, and space for subjective comments regarding taste and tolerability. Participants will be provided with: 1) a collection bottle for overnight urine collection; 2) three frozen GRR-BSE beverages in an insulated cooler bag with a frozen blue-ice block; 3) the intervention diary and instructions, as stated above.
Participants will store the frozen GRR-BSE beverages in their home freezer. On the evening of day 1, participants will collect a baseline overnight void which will be returned to the study team on day 2. Each evening for 3 evenings (days 2-4; between 5pm and 8pm), participants will thaw and consume one GRR-BSE beverage. Beverages may be thawed at room temperature for 1-2 hours, or in a lukewarm (70-80°F) water bath for 20-30 minutes. Participants will record the time of consumption on the intervention diary. AE assessment and buccal cell collections will be conducted on days 3, 4, and 5 (between 8 am and 1 pm) by a study investigator or trained research coordinator. On the evening of day 4, participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary. Blood collection will occur again on day 5 (between 8 am and 1 pm).
Participants will then undergo a minimum 3 day washout. Day 5 of the intervention, which does not include a GRR-BSE dose, counts as the first day of the washout period.
Intervention 2, SFR-BSE
At the baseline visit for intervention 2 (day 1), participants will undergo baseline blood and buccal cell collection. Blood collection will be performed by a trained phlebotomist. Buccal cell collection will be conducted by a trained research coordinator, the principal investigator, or a co-investigator. Participants will receive written and verbal instructions and an intervention diary for documentation of the SFR-BSE drink, details of the intervention timeline, including overnight voids, blood and buccal cell collection, and days of SFR-BSE consumption. Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention. Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention. For overnight voids, participants will be instructed to begin collecting urine at 5 pm, and to collect all urine through the first morning void on the following day. The intervention diary will have space for participants to record the date and time of each SFR-BSE consumption, and space for subjective comments regarding taste and tolerability. Participants will be provided with: 1) a collection bottle for overnight urine collection, including instructions for collection; 2) three frozen SFR-BSE beverages in an insulated cooler bag with a frozen blue-ice block; 3) the intervention diary and instructions, as stated above.
Participants will store the frozen SFR-BSE beverages in their home freezer. On the evening of day 1, participants will collect a baseline overnight void which will be returned to the study team on day 2. Each evening for 3 evenings (days 2-4; between 5pm and 8pm), participants will thaw and consume one SFR-BSE beverage. Beverages may be thawed at room temperature for 1-2 hours, or in a lukewarm (70-80°F) water bath for 20-30 minutes. Participants will record the time of consumption on the intervention diary. AE assessment and buccal cell collections will be conducted on days 3, 4, and 5 (between 8 am and 1 pm) by a study investigator or a trained research coordinator. On the evening of day 4, participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary. Blood collection will occur again on day 5 (between 8 am and 1 pm).
Participants will then undergo a minimum 3 day washout. Day 5 of the intervention, which does not include a SFR-BSE dose, counts as the first day of the washout period.
Intervention 3, SFR-BSE(T)
At the baseline visit for intervention 3 (day 1), participants will undergo baseline blood and buccal cell collection. Blood collection will be performed by a trained phlebotomist. Buccal cell collection will be conducted by a trained research coordinator, the principal investigator, or a co-investigator. Participants will receive written and verbal instructions and an intervention diary for documentation of the SFR-BSE (T) application, details of the intervention timeline, including overnight voids, blood and buccal cell collection, and days of SFR-BSE (T) application. Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention. Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention. For overnight voids, participants will be instructed to begin collecting urine at 5 pm, and to collect all urine through the first morning void on the following day. Participants will be explicitly instructed that intervention 3 is topical application only. Participants will be instructed to take one mouthful (approximately 30 mL or 1/3 of the dose) of the SFR-BSE(T) beverage, swish, gargle, and hold in the mouth for 2-3 minutes then spit out. This will be repeated twice (for a total of 3 swish, gargle, hold and spit applications) until the beverage is gone, aiming for a total exposure time of 6-8 minutes. The intervention diary will have space for participants to record the date, time and duration of each SFR-BSE(T) topical application, and space for subjective comments regarding taste and tolerability. Participants will be provided with: 1) a collection bottle for overnight urine collection, including instructions for collection; 2) three frozen SFR-BSE (T) beverages in an insulated cooler bag with a frozen blue-ice block; 3) the intervention diary and instructions, as stated above.
Participants will store the frozen SFR-BSE(T) beverages in their home freezer. On the evening of day 1, participants will collect a baseline overnight void which will be returned to the study team on day 2. Each evening for 3 evenings (days 2-4; between 5pm and 8pm), participants will thaw and consume one SFR-BSE beverage. Beverages may be thawed at room temperature for 1-2 hours, or in a lukewarm (70-80°F) water bath for 20-30 minutes. Participants will record the time and duration of each topical application on the intervention diary. AE assessment and buccal cell collections will be conducted on days 3, 4, and 5 (between 8 am and 1 pm) by a study investigator. On the evening of day 4, participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary. Blood collection will occur again on day 5 (between 8 am and 1 pm).
- Conditions
- Healthy Subject
- Being tested
- Broccoli Sprout Extract (BSE)
- Keywords
- Oral mucosa, Nrf2 pathway, Broccoli Sprout Extract, Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli Sprout Extract (BSE)Drug
Also called Glucoraphanin-rich BSE (GRR-BSE), Sulforaphane-rich BSE (SFR-BSE)
- The first regimen will involve oral delivery and ingestion of 600 μmole doses of glucoraphanin-rich BSE (GRR-BSE), and will represent systemic delivery of sulforaphane to oral mucosa, due to the necessity to metabolize GRR-BSE in the gut.
- The second regimen will involve oral delivery and ingestion of 100 μmole doses of sulforaphane-rich BSE (SFR-BSE), which will represent a combination of systemic and topical delivery to the oral mucosa.
- The third regimen will isolate topical exposure of the oral mucosa to sulforaphane. Participants will swish, hold, then spit 100 μmole doses of SFR-BSE. This regimen (SFR-BSE(T)) will theoretically isolate the pharmacodynamic impact of topical exposure of the oral mucosa to sulforaphane.
| Study group | Role | What they receive |
|---|---|---|
| Broccoli Sprout Extract Drink | Experimental | Three different regimens of BSE delivery will be evaluated in each participant, with participants serving as their own controls. Each regimen will involve a 3 day exposure, with daily collection of buccal cell scrapings. Between regimens, a minimum 3 day (72 hour) washout period will occur. Receives: Drug: Broccoli Sprout Extract (BSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the modulation of the Nrf2 pathway in response to short term exposure to three BSE regimens
The primary objective is limited to obtaining preliminary estimates of Nrf2 pathway modulation from buccal cell specimens samples all collected during each of the three 5 day intervention periods. Endpoints include mRNA transcript levels of certain genes or enzymes regulated by Nrf2.
Note that the goals of this study are limited to obtaining initial pharmacodynamic estimates of Nrf2 pathway modulation for each BSE intervention. Accordingly, no hypothesis testing or comparative analyses are planned. The data collected in this pilot study may be used to plan a future definitive prevention trial.
Measured: Three to 11 weeks
Secondary outcomes (1)
Estimate modulation of Nrf2 pathway markers in PBMCs and metabolites of SFN in urine
Individual subjects profile plots will be constructed for each endpoint as measured at various times over days 1-5 of each regimen will be plotted. An omnibus test of change over time such as the Friedman test of Mack-Skillings test will be conducted to verify general endpoint modulation. Regimen-specific profiles will be estimated with mixed linear or generalized mixed linear models
Measured: Three to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie E. Bauman, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Julie E. Bauman, MD, MPH, University of Pittsburgh
- Investigators
- Julie E Bauman, MD, Principal investigator, University ofPittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023931
- Sponsor's protocol ID
- 13-079
- Other IDs
- 5P50CA097190-09
- Acronym
- BSE
- Status last verified
- Nov 2017
- First submitted
- 24 Dec 2013
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Broccoli Sprout Extracts in Healthy Volunteers: A Pilot Study of Nrf2 Pathway Modulation in Oral Mucosa
- ClinicalTrials.gov ID
- NCT02023931
- Acronym / sponsor ID
- BSE / 13-079
- Conditions
- Healthy Subject
- Keywords
- Oral mucosa, Nrf2 pathway, Broccoli Sprout Extract, Head and Neck Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Julie E. Bauman, MD, MPHUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study has been designed to determine (primary objective) if three brief interventions with three oral BSE regimens will alter mRNA biomarkers of Nrf2 pathway signaling, including NQO1, GSTs and AKRs, in the oral mucosa of healthy subjects. Quantitative distribution data and preliminary effect size for specific Nrf2 targets, as measured in serial buccal cell scrapings, will be determined during the course of 3-day exposures to three BSE regimens. These data will inform the design of a randomized, phase II chemoprevention trial in patients with HPV-negative HNSCC.
Ten healthy volunteers will be recruited for this pilot study, Age ≥ 18 years, both male and female: 1) The non-cancer population presenting to the University of Pittsburgh Eye and Ear Institute or the Hillman Cancer Center. This may include patients with benign disease or their friends/family members, or friends/family members of patients with cancer; 2) Professionals, staff, or students at the University of Pittsburgh.
Detailed description
Intervention 1, GRR-BSE
If eligible, participants may undergo baseline visit procedures immediately following the screening visit (same day). If necessary for logistical purposes, participants may return for the baseline visit and initiation of the first BSE intervention any time during the 14 days following eligibility assessment. At the baseline visit (day 1), participants will undergo baseline blood and buccal cell collection. Blood collection will be performed by a trained phlebotomist. Buccal cell collection will be conducted by a trained research coordinator, the principal investigator, or a co-investigator. Participants will receive written and verbal instructions and an intervention diary for documentation of the BSE drink, details of the intervention timeline, including overnight voids, blood and buccal cell collection, and days of GRR-BSE consumption. Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention. Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention. For overnight voids, participants will be instructed to begin collecting urine at 5 pm, and to collect all urine through the first morning void on the following day. The intervention diary will have space for participants to record the date and time of each GRR-BSE consumption, and space for subjective comments regarding taste and tolerability. Participants will be provided with: 1) a collection bottle for overnight urine collection; 2) three frozen GRR-BSE beverages in an insulated cooler bag with a frozen blue-ice block; 3) the intervention diary and instructions, as stated above.
Participants will store the frozen GRR-BSE beverages in their home freezer. On the evening of day 1, participants will collect a baseline overnight void which will be returned to the study team on day 2. Each evening for 3 evenings (days 2-4; between 5pm and 8pm), participants will thaw and consume one GRR-BSE beverage. Beverages may be thawed at room temperature for 1-2 hours, or in a lukewarm (70-80°F) water bath for 20-30 minutes. Participants will record the time of consumption on the intervention diary. AE assessment and buccal cell collections will be conducted on days 3, 4, and 5 (between 8 am and 1 pm) by a study investigator or trained research coordinator. On the evening of day 4, participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary. Blood collection will occur again on day 5 (between 8 am and 1 pm).
Participants will then undergo a minimum 3 day washout. Day 5 of the intervention, which does not include a GRR-BSE dose, counts as the first day of the washout period.
Intervention 2, SFR-BSE
At the baseline visit for intervention 2 (day 1), participants will undergo baseline blood and buccal cell collection. Blood collection will be performed by a trained phlebotomist. Buccal cell collection will be conducted by a trained research coordinator, the principal investigator, or a co-investigator. Participants will receive written and verbal instructions and an intervention diary for documentation of the SFR-BSE drink, details of the intervention timeline, including overnight voids, blood and buccal cell collection, and days of SFR-BSE consumption. Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention. Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention. For overnight voids, participants will be instructed to begin collecting urine at 5 pm, and to collect all urine through the first morning void on the following day. The intervention diary will have space for participants to record the date and time of each SFR-BSE consumption, and space for subjective comments regarding taste and tolerability. Participants will be provided with: 1) a collection bottle for overnight urine collection, including instructions for collection; 2) three frozen SFR-BSE beverages in an insulated cooler bag with a frozen blue-ice block; 3) the intervention diary and instructions, as stated above.
Participants will store the frozen SFR-BSE beverages in their home freezer. On the evening of day 1, participants will collect a baseline overnight void which will be returned to the study team on day 2. Each evening for 3 evenings (days 2-4; between 5pm and 8pm), participants will thaw and consume one SFR-BSE beverage. Beverages may be thawed at room temperature for 1-2 hours, or in a lukewarm (70-80°F) water bath for 20-30 minutes. Participants will record the time of consumption on the intervention diary. AE assessment and buccal cell collections will be conducted on days 3, 4, and 5 (between 8 am and 1 pm) by a study investigator or a trained research coordinator. On the evening of day 4, participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary. Blood collection will occur again on day 5 (between 8 am and 1 pm).
Participants will then undergo a minimum 3 day washout. Day 5 of the intervention, which does not include a SFR-BSE dose, counts as the first day of the washout period.
Intervention 3, SFR-BSE(T)
At the baseline visit for intervention 3 (day 1), participants will undergo baseline blood and buccal cell collection. Blood collection will be performed by a trained phlebotomist. Buccal cell collection will be conducted by a trained research coordinator, the principal investigator, or a co-investigator. Participants will receive written and verbal instructions and an intervention diary for documentation of the SFR-BSE (T) application, details of the intervention timeline, including overnight voids, blood and buccal cell collection, and days of SFR-BSE (T) application. Participants will receive a list of brassica vegetables and condiments to avoid during each study intervention. Participants will also receive a list of CYP3A4 inducers and inhibitors that must be avoided during the study intervention. For overnight voids, participants will be instructed to begin collecting urine at 5 pm, and to collect all urine through the first morning void on the following day. Participants will be explicitly instructed that intervention 3 is topical application only. Participants will be instructed to take one mouthful (approximately 30 mL or 1/3 of the dose) of the SFR-BSE(T) beverage, swish, gargle, and hold in the mouth for 2-3 minutes then spit out. This will be repeated twice (for a total of 3 swish, gargle, hold and spit applications) until the beverage is gone, aiming for a total exposure time of 6-8 minutes. The intervention diary will have space for participants to record the date, time and duration of each SFR-BSE(T) topical application, and space for subjective comments regarding taste and tolerability. Participants will be provided with: 1) a collection bottle for overnight urine collection, including instructions for collection; 2) three frozen SFR-BSE (T) beverages in an insulated cooler bag with a frozen blue-ice block; 3) the intervention diary and instructions, as stated above.
Participants will store the frozen SFR-BSE(T) beverages in their home freezer. On the evening of day 1, participants will collect a baseline overnight void which will be returned to the study team on day 2. Each evening for 3 evenings (days 2-4; between 5pm and 8pm), participants will thaw and consume one SFR-BSE beverage. Beverages may be thawed at room temperature for 1-2 hours, or in a lukewarm (70-80°F) water bath for 20-30 minutes. Participants will record the time and duration of each topical application on the intervention diary. AE assessment and buccal cell collections will be conducted on days 3, 4, and 5 (between 8 am and 1 pm) by a study investigator. On the evening of day 4, participants will collect an overnight void which will be returned to the study team on day 5 along with the intervention diary. Blood collection will occur again on day 5 (between 8 am and 1 pm).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Broccoli Sprout Extract Drink | Experimental | Drug: Broccoli Sprout Extract (BSE)Three different regimens of BSE delivery will be evaluated in each participant, with participants serving as their own controls. Each regimen will involve a 3 day exposure, with daily collection of buccal cell scrapings. Between regimens, a minimum 3 day (72 hour) washout period will occur. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years. Children will not be recruited into this study because children do not develop head and neck cancer.
- Both males and females are eligible.
- Members of all racial and ethnic groups are eligible.
- Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration (Appendix B).
- No current or former diagnosis of cancer, with the exception of: excised and cured non-melanoma skin cancer; or carcinoma in situ of the cervix
Key exclusion criteria (1 listed)
- Failure to meet the above criteria
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 (BSE)Also: Glucoraphanin-rich BSE (GRR-BSE), Sulforaphane-rich BSE (SFR-BSE)1. The first regimen will involve oral delivery and ingestion of 600 μmole doses of glucoraphanin-rich BSE (GRR-BSE), and will represent systemic delivery of sulforaphane to oral mucosa, due to the necessity to metabolize GRR-BSE in the gut. 2. The second regimen will involve oral delivery and ingestion of 100 μmole doses of sulforaphane-rich BSE (SFR-BSE), which will represent a combination of systemic and topical delivery to the oral mucosa. 3. The third regimen will isolate topical exposure of the oral mucosa to sulforaphane. Participants will swish, hold, then spit 100 μmole doses of SFR-BSE. This regimen (SFR-BSE(T)) will theoretically isolate the pharmacodynamic impact of topical exposure of the oral mucosa to sulforaphane. | Drug | Broccoli Sprout Extract Drink |
Primary outcome
Determine the modulation of the Nrf2 pathway in response to short term exposure to three BSE regimens
Time frame: Three to 11 weeks
The primary objective is limited to obtaining preliminary estimates of Nrf2 pathway modulation from buccal cell specimens samples all collected during each of the three 5 day intervention periods. Endpoints include mRNA transcript levels of certain genes or enzymes regulated by Nrf2. Note that the goals of this study are limited to obtaining initial pharmacodynamic estimates of Nrf2 pathway modulation for each BSE intervention. Accordingly, no hypothesis testing or comparative analyses are planned. The data collected in this pilot study may be used to plan a future definitive prevention trial.
1 secondary outcome
Estimate modulation of Nrf2 pathway markers in PBMCs and metabolites of SFN in urine
Time frame: Three to 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
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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.
Julie E Bauman, MD principal investigator
University ofPittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Broccoli Sprout Extract (BSE) in people with Healthy Subject, run by Julie E. Bauman, MD, MPH at 2 sites in United States.
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 16 inclusion and 1 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the modulation of the Nrf2 pathway in response to short term exposure to three BSE regimens (time frame: Three to 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2017.