HealthyPhase 2NCT03978117
Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens
A Phase 2 study testing Freeze Dried Watercress Preparation in people with Healthy, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
The goal of this research is to determine if consuming one of two study drinks will help enhance the detoxification of multiple environmental toxicants and cancer causing agents, particularly in subjects who are null for glutathione-S-transferase M1 (GSTM1), glutathione-S-transferase T1 (GSTT1), or both. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Freeze Dried Watercress Preparation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 13 Nov 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult Male or female. Participants can be smokers or non-smokers
- In good physical health
- In stable and good mental health
- Not using any medications that may affect the Nrf2 pathway
- Women who are not pregnant or nursing or planning to become pregnant
- Participants have provided written informed consent to participate in the study
Who cannot join
- Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
- Vital signs outside of the allotted range
- Not willing to abstain from eating cruciferous vegetables during the course of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55405
About this study
The goal of this research is to determine if consuming one of two study drinks will help enhance the detoxification of multiple environmental toxicants and cancer causing agents, particularly in subjects who are null for glutathione-S-transferase M1 (GSTM1), glutathione-S-transferase T1 (GSTT1), or both. If our research supports this idea, this drink could be an inexpensive dietary component, which could promote good health.
Read the detailed description
Volatile organic carcinogens and toxicants are ubiquitous environmental and endogenous compounds to which virtually all humans are exposed. All of these compounds are detoxified by metabolic processes that ultimately result in conjugation with glutathione and excretion of mercapturic acids in urine. Glutathione conjugation can be upregulated by isothiocyanates through the Nrf2 pathway and related routes of metabolism. This study will examine if watercress consumption, resulting in exposure to milligram amounts of 2-phenethyl isothiocyanate (PEITC) per day, will enhance the detoxification of benzene, acrolein and other related volatile toxicants and carcinogens. One of the two drinks contains PEITC released from freeze dried watercress while the other drink contains maltodextrin.
Benzene causes acute myeloid leukemia/acute non-lymphocytic leukemia in humans, and a positive association has been observed between benzene exposure and acute lymphocytic leukemia, chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma. Acrolein is highly toxic and causes nasal tumors in rats. Benzene is classified as "carcinogenic to humans" by the International Agency for Research on Cancer, and acrolein as "probably carcinogenic to humans." Mercapturic acids of the volatile toxicants and carcinogens propylene oxide, crotonaldehyde, methyl vinyl ketone, methacrolein, and acrylonitrile will also be quantified.
The study will be a randomized, placebo-controlled, single-blind, phase II clinical trial with a crossover study design. Participants will be assigned to active (freeze dried watercress) or placebo (maltodextrin) study product for 14 days, then undergo a 4-week wash-out period, and will then be crossed over to the other product for another 14 days. During the treatment phase, subjects will consume the watercress beverage or placebo, three times per day. The target dose will be 40 mg/day of PEITC. Subjects may be titrated down if they report being unable to tolerate the full dose. Urine, oral swabs, and saliva will be collected.
- Conditions
- Healthy
- Being tested
- Freeze Dried Watercress Preparation, Placebo Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze Dried Watercress PreparationDietary supplement
Freeze dried watercress containing gluconasturtiin, which when added to provided water with flavor powder, will result in a total target dose of up to 40 mg/day of 2-phenethyl isothiocyanate (PEITC). Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.
Placebo PreparationDietary supplement
Maltodextrin added to provided water with flavor powder. Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Freeze Dried Watercress Preparation | Experimental | Not described Receives: Dietary Supplement: Freeze Dried Watercress Preparation |
| Placebo Preparation | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carcinogen Detoxification of Metabolites in Urine.
Carcinogen detoxification metabolites in urine. Biomarkers to be analyzed: 2-cyanoethyl mercapturic acid (CEMA), 3-hydroxypropyl mercapturic acid (HPMA1), 2-hydroxypropyl mercapturic acid (HPMA2), phenyl mercapturic acid (SPMA), 3-hydroxy-1-methylpropyl mercapturic acid (HMPMA1), 3-hydroxy-2-methylpropyl mercapturic acid (HMPMA2), and 3-hydroxy-3-methylpropyl mercapturic acid (HMPMA3),
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start18 Feb 2021
- Primary completion19 Dec 2023
- Study completion13 Nov 2024
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 (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dorothy Hatsukami, PhD, Principal investigator, University of MinnesotaStephen Hecht, PhD, Principal investigator, Department of Laboratory Medicine and Pathology, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978117
- Sponsor's protocol ID
- 2018NTLS144
- Other IDs
- 2018NTLS144
- Status last verified
- Nov 2025
- First submitted
- 5 Jun 2019
- Last updated
- 21 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hecht SS, Carmella SG, Basu S, Chen M, Wittman M, Tang MK, Zhao Y, Lu J, Ng D, Heath E, Fujioka N, Egbert A, Strayer L, Usman A, Thomson NM, Murphy SE, Hatsukami DK. A watercress drink increases detoxification of common environmental carcinogens such as acrolein and benzene: results of a randomized clinical trial. Carcinogenesis. 2025 Dec 26;47(1):bgag007. doi: 10.1093/carcin/bgag007.
PubMed 41699775
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens
- ClinicalTrials.gov ID
- NCT03978117
- Acronym / sponsor ID
- 2018NTLS144
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Posted 5 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to determine if consuming one of two study drinks will help enhance the detoxification of multiple environmental toxicants and cancer causing agents, particularly in subjects who are null for glutathione-S-transferase M1 (GSTM1), glutathione-S-transferase T1 (GSTT1), or both. If our research supports this idea, this drink could be an inexpensive dietary component, which could promote good health.
Detailed description
Volatile organic carcinogens and toxicants are ubiquitous environmental and endogenous compounds to which virtually all humans are exposed. All of these compounds are detoxified by metabolic processes that ultimately result in conjugation with glutathione and excretion of mercapturic acids in urine. Glutathione conjugation can be upregulated by isothiocyanates through the Nrf2 pathway and related routes of metabolism. This study will examine if watercress consumption, resulting in exposure to milligram amounts of 2-phenethyl isothiocyanate (PEITC) per day, will enhance the detoxification of benzene, acrolein and other related volatile toxicants and carcinogens. One of the two drinks contains PEITC released from freeze dried watercress while the other drink contains maltodextrin.
Benzene causes acute myeloid leukemia/acute non-lymphocytic leukemia in humans, and a positive association has been observed between benzene exposure and acute lymphocytic leukemia, chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma. Acrolein is highly toxic and causes nasal tumors in rats. Benzene is classified as "carcinogenic to humans" by the International Agency for Research on Cancer, and acrolein as "probably carcinogenic to humans." Mercapturic acids of the volatile toxicants and carcinogens propylene oxide, crotonaldehyde, methyl vinyl ketone, methacrolein, and acrylonitrile will also be quantified.
The study will be a randomized, placebo-controlled, single-blind, phase II clinical trial with a crossover study design. Participants will be assigned to active (freeze dried watercress) or placebo (maltodextrin) study product for 14 days, then undergo a 4-week wash-out period, and will then be crossed over to the other product for another 14 days. During the treatment phase, subjects will consume the watercress beverage or placebo, three times per day. The target dose will be 40 mg/day of PEITC. Subjects may be titrated down if they report being unable to tolerate the full dose. Urine, oral swabs, and saliva will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freeze Dried Watercress Preparation | Experimental | Dietary Supplement: Freeze Dried Watercress Preparation |
| Placebo Preparation | Placebo comparator | Dietary Supplement: Placebo Preparation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult Male or female. Participants can be smokers or non-smokers
- In good physical health
- In stable and good mental health
- Not using any medications that may affect the Nrf2 pathway
- Women who are not pregnant or nursing or planning to become pregnant
Key exclusion criteria (3 listed)
- Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional
- Vital signs outside of the allotted range
- Not willing to abstain from eating cruciferous vegetables during the course of the study
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 |
|---|---|---|
| Freeze Dried Watercress PreparationFreeze dried watercress containing gluconasturtiin, which when added to provided water with flavor powder, will result in a total target dose of up to 40 mg/day of 2-phenethyl isothiocyanate (PEITC). Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks. | Dietary supplement | Freeze Dried Watercress Preparation |
| Placebo PreparationMaltodextrin added to provided water with flavor powder. Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks. | Dietary supplement | Placebo Preparation |
Primary outcome
Carcinogen Detoxification of Metabolites in Urine.
Time frame: 2 Months
Carcinogen detoxification metabolites in urine. Biomarkers to be analyzed: 2-cyanoethyl mercapturic acid (CEMA), 3-hydroxypropyl mercapturic acid (HPMA1), 2-hydroxypropyl mercapturic acid (HPMA2), phenyl mercapturic acid (SPMA), 3-hydroxy-1-methylpropyl mercapturic acid (HMPMA1), 3-hydroxy-2-methylpropyl mercapturic acid (HMPMA2), and 3-hydroxy-3-methylpropyl mercapturic acid (HMPMA3),
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41699775Hecht SS, Carmella SG, Basu S, Chen M, Wittman M, Tang MK, Zhao Y, Lu J, Ng D, Heath E, Fujioka N, Egbert A, Strayer L, Usman A, Thomson NM, Murphy SE, Hatsukami DK. A watercress drink increases detoxification of common environmental carcinogens such as acrolein and benzene: results of a randomized clinical trial. Carcinogenesis. 2025 Dec 26;47(1):bgag007. doi: 10.1093/carcin/bgag007.
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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.
Dorothy Hatsukami, PhD principal investigator
University of Minnesota
Stephen Hecht, PhD principal investigator
Department of Laboratory Medicine and Pathology, University of Minnesota
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 Freeze Dried Watercress Preparation in people with Healthy, run by Masonic Cancer Center, University of Minnesota at 1 site 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 6 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 21 Nov 2025. 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 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. 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 5 Sep 2025). 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?
Carcinogen Detoxification of Metabolites in Urine. (time frame: 2 Months). 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 NCT03978117, which also lists 1 linked publication.
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 21 Nov 2025.