Clinical Trial

A Clinical Trial to Assess the Pharmacokinetic Profile of Propylene Glycol (PG) in Healthy Adults Following PG Exposure

Recruiting
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Summary
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
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-09
Trial Details
NCT Number NCT07644169
Lead Sponsor American Beverage Association
Collaborators: KGK Science Inc.
Conditions Healthy, Pharmacokinetic Profile, Propylene Glycol
Enrollment 30 participants
Start Date 2026-07-02
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-08