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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Freeze dried Powder; Dietary supplement: Placebo Preparation

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hanna Vanderloo, RN, MSN; Phone Number: 612.624.4983; Email: hannav@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55405
      • Recruiting
      • University of Minnesota
      • Contact: Hanna Vanderloo, RN, MSN
      • Principal Investigator: Dorothy Hatsukami, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Freeze dried Powder; Freeze dried powder containing gluconasturtiin, which when added to a provided juice, will result in a 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: Placebo Preparation; Placebo powder added to a provided juice. Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.
Experimental: Freeze Dried Powder Preparation	Dietary supplement: Freeze dried Powder; Freeze dried powder containing gluconasturtiin, which when added to a provided juice, will result in a 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: Placebo Preparation; Placebo powder added to a provided juice. Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of study drink Preparation on toxins	Prevalence of environment toxins in study population	2 Months
Effect of study drink Preparation on carcinogens	Prevalence of carcinogens in study population	2 Months

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stephen Hecht, PhD, Department of Laboratory Medicine and Pathology, University of Minnesota; Principal Investigator: Dorothy Hatsukami, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): September 15, 2025

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: June 5, 2019
• First Posted (Actual): June 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2018NTLS144 (Other Identifier: University of Minnesota Masonic Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No