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CompletedNCT03404011AEPGGIBPUpdated Apr 17, 2019

Acute Effects of Propylene Glycol/Glycerol Intake on Blood Parameters

An interventional study of Propylene glycol and Glycerol intake and Mimicking intake in Metabolic Complication, sponsored by Université Libre de Bruxelles. Completed at 1 site in Belgium. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Université Libre de Bruxelles · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Metabolic Complication
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Propylene glycol and Glycerol intake

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

    Other: Propylene glycol and Glycerol intake

  • Placebo comparator
    Mimicking intake

    Mimicking Propylene glycol/Glycerol intake with the device turns off

    Device: Mimicking intake

Interventions

  • OtherPropylene 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.

  • DeviceMimicking intake

    Mimicking propylene glycol/glycerol intake with the device turns off. Blood sample before, 5 minutes and 20 minutes after intake.

05

What researchers measure

Primary outcomes

  1. Cardiorespiratory biological variables

    Blood sample

    Time frame: 5 minutes

Secondary outcomes

  1. Cardiorespiratory biological variables

    Blood sample

    Time frame: 20 minutes

06

Study locations

1 site
  • Saint-Pierre Hospital
    Brussels, 1000, Belgium
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 28, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — Data will be shared upon reasonnable request

08

Registry details

Key details

Study ID
NCT03404011
Lead sponsor
Université Libre de Bruxelles
Responsible party
Martin Chaumont (MD, Cardiology Fellow, Université Libre de Bruxelles) — Principal investigator
First posted
Jan 19, 2018
Start date
Jan 15, 2018
Primary completion
Dec 30, 2018
Completion
Dec 30, 2018
Last update
Apr 17, 2019

Study contacts

Martin Chaumont, MD
principal investigator · Université Libre de Bruxelles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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