Study probes how common drink additive propylene glycol moves through the body
NCT ID NCT07644169
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This trial investigates how propylene glycol, a common additive in beverages, enters the bloodstream after drinking one, two, or three cans of a propylene glycol-containing drink. Healthy adults aged 18 and older will have their blood drawn to measure peak levels and how the body processes the substance. The goal is to better understand the safety margin of propylene glycol in everyday drinks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- propylene glycol
- What this could lead to
- If successful, this study could help set safer limits for propylene glycol in drinks and foods.
- What could go wrong
- This is a small, early-phase study in healthy adults, so results may not apply to everyone or change current safety guidelines.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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KGK Science Inc.
RECRUITINGLondon, Ontario, N5Y 5V6, Canada
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