Propylene Glycol/Glycerol Intake and Cardiorespiratory Function

Not Applicable

Completed

• Conditions: Lung Injury
• Interventions: Other: Nicotine intake; Other: Cessation intake; Other: Nicotine free intake

• Registration Number: NCT03410511
• Lead Sponsor: Université Libre de Bruxelles

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.

Study Timeline

• Study First Submitted: 2018-01-11
• Study Start: 2018-01-15
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-25
• Primary Completion: 2019-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nicotine intake	Nicotine 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/nicotine (mix 50:50) intake.
Cessation intake	Cessation 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.
Nicotine free intake	Nicotine 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.

Primary Outcome Measures

Name	Time	Method
Change in cardiorespiratory function	4 hours	Continuous monitoring of cardiorespiratory function

Secondary Outcome Measures

Name	Time	Method
Change in serum and urine proteomics profiles	1 hour	Serum and urine proteomics

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussels, Anderlecht, Belgium