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

Sponsor

Université Libre de Bruxelles (Other)

Overall Status

Completed

CT.gov ID

NCT03404011

Collaborator

(none)

Enrollment

Location

Arms

11.5

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 :

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

Study Type:

Interventional

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 :

Jan 15, 2018

Actual Primary Completion Date :

Dec 30, 2018

Actual Study Completion Date :

Dec 30, 2018

Arms and Interventions

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.

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

Primary Outcome Measures

Cardiorespiratory biological variables [5 minutes]
Blood sample

Secondary Outcome Measures

Cardiorespiratory biological variables [20 minutes]
Blood sample

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Saint-Pierre Hospital	Brussels		Belgium	1000

Sponsors and Collaborators

Université Libre de Bruxelles

Investigators

Principal Investigator: Martin Chaumont, MD, Université Libre de Bruxelles

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Jan 28, 2018

More Information

Publications

None provided.

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:

Jan 19, 2018

Last Update Posted:

Apr 17, 2019

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glycerol

Study Results

No Results Posted as of Apr 17, 2019