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

An Open-label, Dose-escalation Clinical Trial to Assess the Pharmacokinetic Profile of Propylene Glycol (PG) in Healthy Adults Following PG Exposure

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

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Pharmacokinetic Profile; Propylene Glycol
• Intervention / Treatment: Other: Propylene glycol

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Lewis, PhD; Phone Number: 248 1-226-242-4551; Email: elewis@kgkscience.com

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N5Y 5V6
      • KGK Science Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Males and females 18 years and older
2. Body Mass Index (BMI) between 18.5 to 29.9 kg/m2

3. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,

   Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

   • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Nexplanon)
   • Double-barrier method
   • Intrauterine devices
   • Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
   • Vasectomy of partner at least 6 months prior to screening
   • Abstinence and agrees to use contraception if planning on becoming sexually active during the study
4. Agrees to refrain from vigorous physical activity and alcohol consumption 24 hours prior to dosing day (i.e., Day 1 of each study period which corresponds to Visits 2, 4, 6) and Day 2 of each study period
5. Willingness to complete diaries, food records, and to complete all clinic visits
6. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
7. Provided voluntary, written, informed consent to participate in the study
8. Healthy as determined by medical history and laboratory results as assessed by the Qualified Investigator (QI)

Exclusion Criteria:

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy, sensitivity, or intolerance, preventing consumption of investigational product ingredients and standardized meal
3. Individuals with alcohol dehydrogenase deficiency as assessed by the QI
4. Poor venous access as assessed by the QI
5. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
6. Significant cardiovascular event in the past 6 months. (Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis.)
7. Self-reported confirmation of any significant neuropsychological condition (e.g., Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, neurodegenerative disease, infections, insomnia, anxiety, depression, epileptic or other seizure-related disorders) as assessed by the QI
8. Unstable metabolic disease or chronic diseases as assessed by the QI
9. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
10. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
11. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
12. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. (Participants with minor surgery will be considered on a case-by-case basis by the QI.)
13. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
14. Individuals with an autoimmune disease or are immune compromised as assessed by the QI.
15. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
16. Self-reported confirmation of blood/bleeding disorders as assessed by the QI
17. Use of prescribed cannabinoid products
18. Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
19. Regular use of e-cigarettes, tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout (1 month) and abstain for the duration of the study period.
20. Alcohol intake average of >1 standard drinks per day as assessed by the QI
21. Alcohol or drug abuse within the last 12 months
22. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the safety of the investigational product (Sections 7.3.1 and 7.3.2)
23. Clinically significant abnormal laboratory results at screening as assessed by the QI
24. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
25. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
26. Individuals who are unable to give informed consent
27. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Propylene glycol-containing beverage; Participants will consume a beverage containing propylene glycol (PG) with standardized meals at Visits 2, 4, and 6.

Other: Propylene glycol; At Visits 2, 4, and 6, participants will consume 1X, 2X, and 3X 12 oz of a PG-containing beverage (in bottle format) with standardized meals in the presence of the study staff over the course of the dosing day. Participants will consume the beverage and standardized meal within 15 minutes. The only beverage allowed during the visit - other than the intent-to-treat beverage - will be water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum concentration of propylene glycol in serum	The maximum concentration (Cmax) of propylene glycol (PG) in serum following consumption of one, two, or three PG-containing beverages.	From pre-dose through 24 hours post-dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum PG Levels	The difference in baseline serum PG levels between each study period.	Baseline (pre-dose) at each dosing visit
Tmax	Assessment of Tmax for PG following consumption of one, two, or three PG containing beverages.	From pre-dose through 24 hours post-dose
Area Under the Curve (AUC0-24hrs)	Assessment of Area Under the Curve (AUC0-24hrs) for PG following consumption of one, two, or three PG containing beverages.	From pre-dose through 24 hours post-dose
AUC0-∞	Assessment of AUC0-∞ for PG following consumption of one, two, or three PG containing beverages.	From pre-dose through 24 hours post-dose
Terminal elimination half-life (t1/2)	Assessment of terminal elimination half-life (t1/2) for PG following consumption of one, two, or three PG containing beverages.	From pre-dose through 24 hours post-dose
Measured and calculated osmolality	Analysis of osmolality at baseline (0 hour) and at each timepoint (0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, 24 hours) following consumption of one, two, or three PG containing beverages. Calculated osmolality will be derived from serum sodium, urea, and glucose concentrations.	Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
Blood osmolal gap	Analysis of blood osmolal gap at baseline (0 hour) and at each timepoint (0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, 24 hours) following consumption of one, two, or three PG containing beverages.	Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
Serum lactate concentration	Analysis of serum lactate concentrations at baseline (0 hour) and at each timepoint (0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, 24 hours) following consumption of one, two, or three PG containing beverages.	Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose
pyruvate concentration	Analysis of pyruvate concentrations at baseline (0 hour) and at each timepoint (0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, 24 hours) following consumption of one, two, or three PG containing beverages.	Assessed at baseline (0 hour) and at 0.5 hour, 1 hour, 1.5 hours, 2 hours, 4 hours, 5 hours, 6 hours, 8 hours, 9 hours, 12 hours, and 24 hours post-dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically relevant changes in blood pressure after supplementation	Clinically relevant changes in blood pressure (mmHg) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in aspartate aminotransferase	Clinically relevant changes in aspartate aminotransferase (U/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in red blood cell count	Clinically relevant changes in red blood cell count (x 10^12/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in heart rate after supplementation	Clinically relevant changes in heart rate (beats per minute) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in body temperature after supplementation	Clinically relevant changes in body temperature (°C) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in oxygen levels after supplementation	Clinically relevant changes in oxygen levels (%) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in alanine aminotransferase	Clinically relevant changes in alanine aminotransferase (U/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in alkaline phosphatase	Clinically relevant changes in alkaline phosphatase (U/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in total bilirubin	Clinically relevant changes in total bilirubin (micromole/litre) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in creatinine	Clinically relevant changes in creatinine (micromole/litre) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in sodium	Clinically relevant changes in sodium (mmol/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in potassium	Clinically relevant changes in potassium (mmol/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in chloride	Clinically relevant changes in chloride (mmol/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in estimated glomerular filtration rate	Clinically relevant changes in estimated glomerular filtration rate (mL/min/1.73 m^2) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in glucose	Clinically relevant changes in glucose (mmol/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in white blood cell count	Clinically relevant changes in white blood cell (x 10^9/L) count following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in platelet count	Clinically relevant changes in platelet count (x10^9/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in hemoglobin	Clinically relevant changes in hemoglobin (g/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in hematocrit	Clinically relevant changes in hematocrit (L/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in red blood cell indices (MCV)	Clinically relevant changes in MCV (fL) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in red blood cell indices (MCH)	Clinically relevant changes in MCH (pg) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in red blood cell indices (MCHC)	Clinically relevant changes in MCHC (g/L) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in RDW	Clinically relevant changes in RDW (%) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)
Clinically relevant changes in red blood cell indices (MPV)	Clinically relevant changes in MPV (fL) following consumption of PG-containing beverages.	From screening (Day -45 to Day -1) through study completion (Visit 7, Day 12)

Collaborators and Investigators

• Sponsor: American Beverage Association
• Collaborators: KGK Science Inc.
• Investigators: Principal Investigator: David Crowley, KGK Science Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: propylene glycol
• Additional Relevant MeSH Terms: Organic Chemicals; Alcohols; Glycols; Propylene Glycols; Propylene Glycol
• Other Study ID Numbers: 26ABAKC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Access Criteria: Upon request (with justification provided), as agreed to by the sponsor. The confidentiality of the participants must be preserved and blinded.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No