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NCT03410511 Clinical Trial

Propylene Glycol/Glycerol Intake and Cardiorespiratory Function

Lung Injury Clinical Trial

— PGGICF  

Official title:
Reversibility of Propylene Glycol/Glycerol Intake Effects on Cardiorespiratory Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03410511
Other study ID # P2016/466 / B406201629930
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2018
Est. completion date June 30, 2020

Study information
Verified date November 2020
Source Université Libre de Bruxelles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 30, 2020
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• 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.
• 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 (mix 50:50) 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.

Locations
Country Name City State
Belgium Erasme Hospital Brussels Anderlecht

Sponsors (1)
Lead Sponsor Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Other Change in serum and exhaled breath condensate metabolomics profiles Serum and exhaled breath condensate metabolomics 1 hour
Primary Change in cardiorespiratory function Continuous monitoring of cardiorespiratory function 4 hours
Secondary Change in serum and urine proteomics profiles Serum and urine proteomics 1 hour
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