Propylene Glycol/Glycerol Intake and Cardiorespiratory Function (PGGICF)

November 2, 2020 updated by: Martin Chaumont, Université Libre de Bruxelles

Reversibility of Propylene Glycol/Glycerol Intake Effects on Cardiorespiratory Function

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Anderlecht
      • Brussels, Anderlecht, Belgium, 1070
        • Erasme hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiorespiratory function
Time Frame: 4 hours
Continuous monitoring of cardiorespiratory function
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum and urine proteomics profiles
Time Frame: 1 hour
Serum and urine proteomics
1 hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum and exhaled breath condensate metabolomics profiles
Time Frame: 1 hour
Serum and exhaled breath condensate metabolomics
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Any purpose Proposals should be directed to martin.chaumont@ulb.ac.be

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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