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Clinical Trials/NCT03404011
NCT03404011CompletedNot Applicable

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

Université Libre de Bruxelles1 site in 1 country24 target enrollmentStarted: January 15, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Cardiorespiratory biological variables

Study Overview

Brief Summary

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

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
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

Arms & Interventions

Propylene glycol and Glycerol intake

Experimental

One gram intake of a Propylene glycol/Glycerol mix (50:50)

Intervention: Propylene glycol and Glycerol intake (Other)

Mimicking intake

Placebo Comparator

Mimicking Propylene glycol/Glycerol intake with the device turns off

Intervention: Mimicking intake (Device)

Outcomes

Primary Outcomes

Cardiorespiratory biological variables

Time Frame: 5 minutes

Blood sample

Secondary Outcomes

  • Cardiorespiratory biological variables(20 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Martin Chaumont

MD, Cardiology Fellow

Université Libre de Bruxelles

Study Sites (1)

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