NCT03404011

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

April 17, 2019

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

January 11, 2018

Last Update Submit

April 15, 2019

Conditions

Metabolic Complication

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory biological variables

    Blood sample

    5 minutes

Secondary Outcomes (1)

  • Cardiorespiratory biological variables

    20 minutes

Study Arms (2)

Propylene glycol and Glycerol intake

EXPERIMENTAL

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

Other: Propylene glycol and Glycerol intake

Mimicking intake

PLACEBO COMPARATOR

Mimicking Propylene glycol/Glycerol intake with the device turns off

Device: Mimicking intake

Interventions

Propylene glycol and Glycerol intakeOTHER

Intake of 1 gram of propylene glycol/Glycerol mix (50:50). Blood sample before, 5 minutes and 20 minutes after intake.

Propylene glycol and Glycerol intake
Mimicking intakeDEVICE

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

Mimicking intake

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint-Pierre Hospital

Brussels, 1000, Belgium

Location

MeSH Terms

Interventions

Propylene Glycol

Intervention Hierarchy (Ancestors)

Propylene GlycolsGlycolsAlcoholsOrganic Chemicals

Study Officials

  • Martin Chaumont, MD

    Université Libre de Bruxelles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Cardiology Fellow

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 19, 2018

Study Start

January 15, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

April 17, 2019

Record last verified: 2018-10

Locations

BE(1)