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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03404011
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Chaumont, Université Libre de Bruxelles

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

Condition or disease Intervention/treatment Phase
Metabolic Complication Other: Propylene glycol and Glycerol intake Device: Mimicking intake Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Acute Effects of Propylene Glycol/Glycerol Intake on Cardiorespiratory Blood Parameters
Actual Study Start Date : January 15, 2018
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Cardiorespiratory biological variables [ Time Frame: 5 minutes ]
    Blood sample


Secondary Outcome Measures :
  1. Cardiorespiratory biological variables [ Time Frame: 20 minutes ]
    Blood sample


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03404011


Locations
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Belgium
Saint-Pierre Hospital
Brussels, Belgium, 1000
Sponsors and Collaborators
Université Libre de Bruxelles
Investigators
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Principal Investigator: Martin Chaumont, MD Université Libre de Bruxelles
  Study Documents (Full-Text)

Documents provided by Martin Chaumont, Université Libre de Bruxelles:
Study Protocol and Statistical Analysis Plan  [PDF] January 28, 2018

More Information
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Responsible Party: Martin Chaumont, MD, Cardiology Fellow, Université Libre de Bruxelles
ClinicalTrials.gov Identifier: NCT03404011    
Other Study ID Numbers: Université Libre de Bruxelles
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared upon reasonnable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs