Propylene Glycol Exposure for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to determine the translation of propylene glycol (PG) exposure in beverages to circulating PG levels to better understand the margin of safety in healthy participants. The main question it aims to answer is what is the maximum concentration (Cmax) of propylene glycol (PG) in serum following consumption of one, two, or three PG-containing beverages? Participants will be asked to:
* Consume 1x, 2x, and 3x 12oz of PG-containing beverage
* Have their blood drawn
* Complete urine pregnancy testing if of childbearing potential
* Complete a study diary and record their food and beverage consumption
* Have their vital signs and oxygen measurements taken
Who Is on the Research Team?
David Crowley
Principal Investigator
KGK Science Inc.
Are You a Good Fit for This Trial?
This trial is for healthy adults age 18 or older with a BMI between 18.5 and 29.9. Women must not be pregnant and must use reliable birth control if of childbearing potential. Participants need to avoid alcohol and strenuous exercise before study visits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants consume 1x, 2x, and 3x 12oz of PG-containing beverage and undergo various assessments including blood draws and vital sign measurements
Follow-up
Participants are monitored for safety and effectiveness after treatment, including clinically relevant changes in various health parameters
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests how much propylene glycol (PG) enters the bloodstream after drinking one, two, or three PG-containing beverages. Blood samples are taken at different times to measure PG levels.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will consume a beverage containing propylene glycol (PG) with standardized meals at Visits 2, 4, and 6.
Find a Clinic Near You
Who Is Running the Clinical Trial?
American Beverage Association
Lead Sponsor
KGK Science Inc.
Industry Sponsor
Najla Guthrie
KGK Science Inc.
Chief Executive Officer since 1997
Research career at the Centre for Human Nutrition, University of Western Ontario
Dr. Bibiane Zakaria
KGK Science Inc.
Chief Medical Officer since 2023
MD from an unspecified institution
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