PGGICF: Propylene Glycol/Glycerol Intake and Cardiorespiratory Function

Sponsor
Université Libre de Bruxelles (Other)
Overall Status
Completed
CT.gov ID
NCT03410511
Collaborator
(none)
30
1
3
29.5
1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Nicotine free intake
  • Other: Nicotine intake
  • Other: Cessation intake
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Reversibility of Propylene Glycol/Glycerol Intake Effects on Cardiorespiratory Function
Actual Study Start Date :
Jan 15, 2018
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

Experimental: 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.

Other: 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.

Experimental: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Change in cardiorespiratory function [4 hours]

    Continuous monitoring of cardiorespiratory function

Secondary Outcome Measures

  1. Change in serum and urine proteomics profiles [1 hour]

    Serum and urine proteomics

Other Outcome Measures

  1. Change in serum and exhaled breath condensate metabolomics profiles [1 hour]

    Serum and exhaled breath condensate metabolomics

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Erasme Hospital Brussels Anderlecht Belgium 1070

Sponsors and Collaborators

  • Université Libre de Bruxelles

Investigators

  • Study Director: Philippe van de Borne, MD, PhD, Université Libre de Bruxelles

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Martin Chaumont, Principal investigator, Université Libre de Bruxelles
ClinicalTrials.gov Identifier:
NCT03410511
Other Study ID Numbers:
  • P2016/466 / B406201629930
First Posted:
Jan 25, 2018
Last Update Posted:
Nov 3, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2020