Universitair Ziekenhuis Gent
Responsive
Gent, Belgium
Not recruiting
Study on the Effects of Pseudoephedrine on Cycling Performance in Healthy Volunteers
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on understanding the effects of pseudoephedrine on cycling performance. Pseudoephedrine is a medication commonly used to relieve nasal congestion. The study involves healthy volunteers who are highly trained athletes. The main goal is to see how a full dose of 240 mg of pseudoephedrine affects cycling performance after a challenging race simulation.
Participants in the study will be given either pseudoephedrine or a placebo to compare the effects. The study will look at changes in cycling performance, such as the time it takes to complete a trial and the average power output. It will also examine how pseudoephedrine affects various body functions, including heart and metabolic activities, during a 90-minute cycling simulation.
The study will also measure the concentration of pseudoephedrine in the blood and urine after taking the medication. This will help determine the threshold levels of pseudoephedrine in the body. The trial aims to provide insights into how pseudoephedrine can influence endurance performance in athletes.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
8 criteria
- Must be a healthy volunteer.
- For men: Must have a VO2max greater than 60 ml/min/kg of body weight. VO2max is a measure of the maximum amount of oxygen your body can use during intense exercise.
- For women: Must have a VO2max greater than 50 ml/min/kg of body weight.
- Must train for more than 10 hours per week, including more than 3 hours of cycling training.
- Must have medical approval to compete in sports. This means a doctor has confirmed you are healthy enough to participate in competitive sports.
- Must be between 18 and 40 years old.
- For women: Must be using hormonal birth control (either combined estrogen and progestogen or progestogen-only) for more than 1 month, according to guidelines.
- Must speak Dutch.
Who cannot join the trial?
4 criteria
- Participants must be healthy volunteers. This means they should not have any medical conditions.
- Participants should be in a specific age range, which is typically defined by the study.
- Both male and female participants are allowed.
- Participants should not be part of a vulnerable population. This means they should not be in a group that might be at higher risk of harm or exploitation.
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Investigated drugs
Pseudoephedrine is a medication commonly used to relieve nasal congestion caused by colds, allergies, or hay fever. In this clinical trial, it is being studied to see if it can improve cycling performance in athletes after they have completed a very tiring race simulation. The researchers want to understand how this medication might help athletes perform better by possibly increasing their endurance or energy levels during intense physical activity.
What is already known about the treatment
Pseudoephedrine – Pseudoephedrine is typically administered orally in the form of tablets or capsules. It is currently being studied for its potential to enhance endurance performance, particularly in highly trained athletes, as part of ongoing clinical trials. The main therapeutic use of pseudoephedrine is as a decongestant to relieve nasal congestion in conditions like colds and allergies. At the molecular level, pseudoephedrine works by stimulating the release of norepinephrine, which leads to the constriction of blood vessels and reduced swelling in the nasal passages. It is classified pharmacologically as a sympathomimetic agent.
Investigated diseases
Healthy volunteers – This term refers to individuals who do not have any known medical conditions or diseases. They are often used in clinical trials to establish baseline data or to test the effects of new treatments or interventions. Healthy volunteers typically have normal physiological functions and are free from chronic illnesses. Their participation helps researchers understand how a treatment affects a typical, healthy body. They are crucial for comparing results with those from individuals who have specific medical conditions. The health status of these volunteers is usually confirmed through medical examinations and history assessments.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513810-36-00Protocol codeONZ-2023-0546Estimated enrolment30 patientsSponsorUniversiteit Gent
sourced from the EU Clinical Trials Register and site verification
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