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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Freeze dried Powder; Dietary Supplement: Placebo Preparation

• Registration Number: NCT03978117
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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

Not available

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Study Start: 2021-02-18
• Primary Completion: 2023-12-19
• Study Completion: 2024-11-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Freeze Dried Powder Preparation	Placebo Preparation	-
Placebo	Placebo Preparation	-
Placebo	Freeze dried Powder	-
Freeze Dried Powder Preparation	Freeze dried Powder	-

Primary Outcome Measures

Name	Time	Method
Effect of study drink Preparation on toxins	2 Months	Prevalence of environment toxins in study population
Effect of study drink Preparation on carcinogens	2 Months	Prevalence of carcinogens in study population

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States