Propylene Glycol/Glycerol Intake and Cardiorespiratory Function (PGGICF)

Université Libre de Bruxelles

Status: Completed

Conditions: Lung Injury

Treatments: Other: Cessation intake; Other: Nicotine intake; Other: Nicotine free intake

Study type: Interventional

Funder types: Other

Identifiers

NCT03410511

P2016/466 / B406201629930

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Nicotine free intake

Experimental group

Description:

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.

Treatment:

Other: Nicotine free intake

Nicotine intake

Experimental group

Description:

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.

Treatment:

Other: Nicotine intake

Cessation intake

Experimental group

Description:

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.

Treatment:

Other: Cessation intake