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View on ClinicalTrials.gov

Testing Propylene glycol for healthy

Official title: 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

Condition: HealthySponsor: American Beverage AssociationTarget enrollment: 30
  • 1 group
  • One site, in London
  • Recruiting
KGK Science Inc., London, Ontario

Interventions

  • Other intervention

    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.

Canadian Sites (1)

1 of 1 recruiting

  • KGK Science Inc.

    London, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for42 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Body Mass Index (BMI) between 18.5 to 29.9 kg/m2
  • +Individuals of child-bearing potential must have a negative baselineBaselineYour starting measurements, taken before treatment begins.Read more → urine pregnancy test and agree to use a medically approved method of birth controlControl groupThe group a new treatment is measured against.Read more → 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:
  • +Males and females 18 years and older
  • +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more → Or,
  • +Double-barrier method
  • +Intrauterine devices
  • +Vasectomy of partner at least 6 months prior to screening
  • +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
  • +Willingness to complete diaries, food records, and to complete all clinic visits
  • +Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
  • +Provided voluntary, written, informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to participate in the study
  • +Healthy as determined by medical history and laboratory results as assessed by the Qualified InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → (QI)
  • +Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Nexplanon)
  • +Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
  • +Abstinence and agrees to use contraception if planning on becoming sexually active during the study

Exclusion

  • Allergy, sensitivity, or intolerance, preventing consumption of investigational product ingredients and standardized meal
  • Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
  • Individuals with alcohol dehydrogenase deficiency as assessed by the QI
  • Poor venous access as assessed by the QI
  • 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
  • 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.)
  • 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
  • Unstable metabolic disease or chronic diseases as assessed by the QI
  • Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
  • Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
  • 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
  • Individuals with an autoimmune disease or are immune compromised as assessed by the QI.
  • Self-reported confirmation of blood/bleeding disorders as assessed by the QI
  • Use of prescribed cannabinoid products
  • Chronic use of cannabinoid products (\>2 times/week). Occasional users will be required to washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → and abstain for the duration of the study period
  • Alcohol intake average of \>1 standard drinks per day as assessed by the QI
  • Alcohol or drug abuse within the last 12 months
  • 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)
  • Clinically significant abnormal laboratory results at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → as assessed by the QI
  • Blood donation 30 days prior to baselineBaselineYour starting measurements, taken before treatment begins.Read more →, during the study, or a planned donation within 30 days of the last study visit
  • Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
  • Individuals who are unable to give informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • 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
  • Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
  • 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.)
  • Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow upFollow-upContinued check-ins after the treatment part is finished.Read more → that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
  • 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.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is investigating how something functions in the body, rather than testing a treatment directly.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

Everyone in this study is in one group and receives Propylene glycol.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

There is only one group in this study, so there is no assignment to different treatments.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 30 people.

The study is currently expected to finish around August 2026.

The main measurement is taken over: From pre-dose through 24 hours post-dose.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

The maximum concentration of propylene glycol in serum — measured over From pre-dose through 24 hours post-dose.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07644169 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Propylene glycolOther

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.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

There is only one group in this study, so there is no assignment to different treatments.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: From pre-dose through 24 hours post-dose..

The study as a whole is currently expected to finish around 2026-08.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 30 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: London, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About 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

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.