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Propylene Glycol/Glycerol Intake and Cardiorespiratory Function

Reversibility of Propylene Glycol/Glycerol Intake Effects on Cardiorespiratory Function

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03410511
Acronym
PGGICF
Enrollment
30
Registered
2018-01-25
Start date
2018-01-15
Completion date
2020-06-30
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Injury

Brief summary

Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown.

Detailed description

Background. Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown. Weaning of propylene glycol/glycerol could allows a quick clearance of propylene glycol/glycerol from the body, with subsequent recovery of cardiorespiratory function. Specific aim of the research. This research proposal tests the following hypothesis regarding the reversibility of propylene glycol/glycerol and nicotine intake: * Propylene glycol/glycerol cessation restores cardiorespiratory function. * Chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine proteomics profile, which are partially reversed after cessation. * Chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine metabolomics profile, which are partially reversed after cessation.

Interventions

OTHERNicotine intake

The participant will pursuit his regular nicotinic propylene/glycerol intake five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.

OTHERCessation intake

The participant will completely stop his regular nicotinic propylene/glycerol intake during five days before the session. At the start of the experimental session, participants will mimick intake with the device turns off.

OTHERNicotine free intake

The participant will wean off nicotine during five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.

Sponsors

Université Libre de Bruxelles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Subject must be regular propylene glycol/glycerol/nicotine intake users since at least 1 year * Subject must be former smokers

Exclusion criteria

* Chronic or acute illness * Substance abuse * Chronic medication intake

Design outcomes

Primary

MeasureTime frameDescription
Change in cardiorespiratory function4 hoursContinuous monitoring of cardiorespiratory function

Secondary

MeasureTime frameDescription
Change in serum and urine proteomics profiles1 hourSerum and urine proteomics

Other

MeasureTime frameDescription
Change in serum and exhaled breath condensate metabolomics profiles1 hourSerum and exhaled breath condensate metabolomics

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026