Measuring Blood Levels of Propylene Glycol After Drinking PG-Containing Beverages in Healthy Adults

What this Trial Is About

Researchers are studying how propylene glycol PG from beverages affects its levels in the blood of healthy adults. The study aims to find the highest concentration Cmax of PG in the serum after drinking one, two, or three PG-containing beverages. The goal is to understand the safety margin of PG exposure in healthy people by measuring how their bodies process this ingredient. Participants will consume a PG-containing beverage in doses of 12 ounces at three visits once, twice, and three times the amount. These drinks are taken with standardized meals under staff supervision, and only water is allowed besides the study drink. This sequential dosing occurs at visits 2, 4, and 6, with each beverage consumed within 15 minutes alongside the meal. During the study, participants will have blood samples taken to measure PG and related blood markers over 24 hours after dosing. They will also provide urine pregnancy tests if applicable, record their food and beverage intake in diaries, and have vital signs monitored. The main measurement is the peak PG level in serum, with additional assessments like blood osmolality and lactate concentrations taken at multiple time points after dosing. Total participation time covers all scheduled visits and assessments.

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