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

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ClinicalTrials.gov Identifier: NCT03978117
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : April 5, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Description
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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
Healthy Dietary Supplement: Freeze dried Powder Dietary Supplement: Placebo Preparation Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 18, 2021
Estimated Primary Completion Date : February 15, 2023
Estimated Study Completion Date : September 15, 2023
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Effect of study drink Preparation on toxins [ Time Frame: 2 Months ]
    Prevalence of environment toxins in study population

  2. Effect of study drink Preparation on carcinogens [ Time Frame: 2 Months ]
    Prevalence of carcinogens in study population


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978117


Contacts
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Contact: Hanna Vanderloo, RN, MSN 612.624.4983 hannav@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55405
Contact: Hanna Vanderloo, RN, MSN         
Principal Investigator: Dorothy Hatsukami, Ph.D         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota
Principal Investigator: Stephen Hecht, PhD Department of Laboratory Medicine and Pathology, University of Minnesota
More Information
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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT03978117    
Other Study ID Numbers: LMP-2018-25528
2018NTLS144 ( Other Identifier: University of Minnesota Masonic Cancer Center )
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No