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

U

Université Libre de Bruxelles

Status

Completed

Conditions

Metabolic Complication

Treatments

Other: Propylene glycol and Glycerol intake
Device: Mimicking intake

Study type

Interventional

Funder types

Other

Identifiers

NCT03404011
Université Libre de Bruxelles

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

24 participants in 2 patient groups, including a placebo group

Propylene glycol and Glycerol intake
Experimental group
Description:
One gram intake of a Propylene glycol/Glycerol mix (50:50)
Treatment:
Other: Propylene glycol and Glycerol intake
Mimicking intake
Placebo Comparator group
Description:
Mimicking Propylene glycol/Glycerol intake with the device turns off
Treatment:
Device: Mimicking intake

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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