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

NCT03978117 | Completed Phase 2 Results

• 1 other identifier: 2018NTLS144
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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),

  2 Months

Study Arms (2)

Freeze Dried Watercress Preparation

EXPERIMENTAL

Dietary Supplement: Freeze Dried Watercress Preparation

Placebo Preparation

PLACEBO COMPARATOR

Dietary Supplement: Placebo Preparation

Interventions

Freeze Dried Watercress Preparation 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.

Freeze Dried Watercress Preparation

Placebo Preparation DIETARY_SUPPLEMENT

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

Placebo Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55405, United States

Location

Results Point of Contact

• Title: Dorothy Hatsukami, PhD
• Organization: Masonic Cancer Center

hatsu001@umn.edu

(612) 626-2121

Study Officials

• Dorothy Hatsukami, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Stephen Hecht, PhD

  Department of Laboratory Medicine and Pathology, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: February 18, 2021
• Primary Completion: December 19, 2023
• Study Completion: November 13, 2024
• Last Updated: November 21, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-11

Locations

US (1)