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

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT03978117
Collaborator
National Cancer Institute (NCI) (NIH)
350
Enrollment
1
Location
2
Arms
30.9
Anticipated Duration (Months)
11.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Freeze dried Powder
  • Dietary Supplement: Placebo Preparation
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Clinical Trial of Two Study Drinks in Detoxification of Environmental Toxicants and Carcinogens
Actual Study Start Date :
Feb 18, 2021
Anticipated Primary Completion Date :
Feb 15, 2023
Anticipated Study Completion Date :
Sep 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

  1. Effect of study drink Preparation on toxins [2 Months]

    Prevalence of environment toxins in study population

  2. Effect of study drink Preparation on carcinogens [2 Months]

    Prevalence of carcinogens in study population

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55405

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Dorothy Hatsukami, PhD, University of Minnesota
  • Principal Investigator: Stephen Hecht, PhD, Department of Laboratory Medicine and Pathology, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT03978117
Other Study ID Numbers:
  • LMP-2018-25528
  • 2018NTLS144
First Posted:
Jun 6, 2019
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 5, 2022