Acute Effects of Propylene Glycol/Glycerol Intake on Blood Parameters (AEPGGIBP)

April 15, 2019 updated by: Martin Chaumont, Université Libre de Bruxelles

Acute Effects of Propylene Glycol/Glycerol Intake on Cardiorespiratory Blood Parameters

The aim of this study is to evaluate the acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background : Propylene glycol/glycerol intake is increasingly popular. Acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters is unknown. The investigators postulate that intake of propylene glycol and glycerol could modifiy cardiorespiratory blood parameters.

Aims of this study : to test the following hypotheses :

1) Acute intake of propylene glycol and glycerol modifies cardiorespiratory blood parameters.

To test this hypothesis, we will perform blood samples before and after intake of propylene glycol and glycerol. Participants will be tobacco smoker between 18 and 70 years old, with multiple cardiovascular risk factors, and who will undergo a cardiac catherization. After the cardiac catherization, the catheter will be used to perform serial blood samples.

Study Type

Interventional

Enrollment (Actual)

24

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

  • Belgium
      • Brussels, Belgium, 1000
        • Saint-Pierre 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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject undergoing cardiac catherization
  • Subject must be an active tobacco smoker

Exclusion Criteria:

  • Symptoms of infection or inflammation
  • Acute disease including heart rhythm disorder, acute coronary syndrome or decompensation of a chronic disease (heart failure, COPD,...)
  • Unexpected and undesirable effects during the cardiac catherization procedure
  • Respiratory failure requiring supplementary oxygen

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propylene glycol and Glycerol intake
One gram intake of a Propylene glycol/Glycerol mix (50:50)
Other: Propylene glycol and Glycerol intake
Intake of 1 gram of propylene glycol/Glycerol mix (50:50). Blood sample before, 5 minutes and 20 minutes after intake.
Placebo Comparator: Mimicking intake
Mimicking Propylene glycol/Glycerol intake with the device turns off
Device: Mimicking intake
Mimicking propylene glycol/glycerol intake with the device turns off. Blood sample before, 5 minutes and 20 minutes after intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory biological variables
Time Frame: 5 minutes
Blood sample
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory biological variables
Time Frame: 20 minutes
Blood sample
20 minutes

Collaborators and Investigators

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

Sponsor

Université Libre de Bruxelles

Investigators

  • Principal Investigator: Martin Chaumont, MD, 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)

December 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Université Libre de Bruxelles

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data will be shared upon reasonnable request

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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