Acute Effects of Propylene Glycol/Glycerol Intake on Blood Parameters

Not Applicable

Completed

• Conditions: Metabolic Complication
• Interventions: Device: Mimicking intake; Other: Propylene glycol and Glycerol intake

• Registration Number: NCT03404011
• Lead Sponsor: Université Libre de Bruxelles

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 Timeline

• Study First Submitted: 2018-01-11
• Study Start: 2018-01-15
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-19
• Status Verified: 2018-10
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mimicking intake	Mimicking intake	Mimicking Propylene glycol/Glycerol intake with the device turns off
Propylene glycol and Glycerol intake	Propylene glycol and Glycerol intake	One gram intake of a Propylene glycol/Glycerol mix (50:50)

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory biological variables	5 minutes	Blood sample

Secondary Outcome Measures

Name	Time	Method
Cardiorespiratory biological variables	20 minutes	Blood sample

Trial Locations

Locations (1)

Saint-Pierre Hospital; 🇧🇪 Brussels, Belgium