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Completed

NCT Number: NCT03410511

Propylene Glycol/Glycerol Intake and Cardiorespiratory Function

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

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Key information

Conditions

Lung Injury Lung Diseases Respiratory Tract Diseases Thoracic Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, Anderlecht, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine free intake

Other

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.

Nicotine intake

Other

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.

Cessation intake

Other

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.

Primary outcomes

  1. Change in cardiorespiratory function

    Time frame: 4 hours

    Continuous monitoring of cardiorespiratory function

Secondary outcomes

  1. Change in serum and urine proteomics profiles

    Time frame: 1 hour

    Serum and urine proteomics

Other outcomes

  1. Change in serum and exhaled breath condensate metabolomics profiles

    Time frame: 1 hour

    Serum and exhaled breath condensate metabolomics

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Registry information

Official study title

Reversibility of Propylene Glycol/Glycerol Intake Effects on Cardiorespiratory Function

Acronym: PGGICF

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 25, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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