Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens

NCT ID: NCT03978117

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-18
• Study Completion Date: 2024-11-13

Brief 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. 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Freeze Dried Watercress Preparation

Group Type: EXPERIMENTAL

Freeze Dried Watercress Preparation

Intervention Type: DIETARY_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 Preparation

Group Type: PLACEBO_COMPARATOR

Placebo Preparation

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin added to provided water with flavor powder. Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.

Interventions

Freeze Dried Watercress Preparation

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Preparation

Maltodextrin added to provided water with flavor powder. Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorothy Hatsukami, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Stephen Hecht, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Laboratory Medicine and Pathology, University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018NTLS144

Identifier Type: OTHER

Identifier Source: secondary_id

2018NTLS144

Identifier Type: -

Identifier Source: org_study_id