Study on the Effects of Pseudoephedrine on Cycling Performance in Healthy Volunteers

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What is this study about?

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.

1 initial visit

Upon joining the study, participants will attend an initial visit. During this visit, eligibility will be confirmed based on specific criteria such as age, training volume, and medical approval for competitive sports.

Participants will be informed about the study procedures, and any questions will be addressed. Consent will be obtained to ensure understanding and agreement to participate.

2 baseline assessment

Participants will undergo a baseline assessment to measure their current physical performance and physiological parameters. This may include tests to determine VO2max, which is a measure of the maximum amount of oxygen the body can use during intense exercise.

These assessments will help establish a starting point for comparing changes throughout the study.

3 placebo trial

Participants will take part in a cycling performance test after ingesting a placebo, which contains no active medication. This trial will help establish a baseline for comparison with trials involving the active medication.

The duration and average power output during this trial will be recorded for later analysis.

4 half-dose trial

Participants will ingest a half-dose of pseudoephedrine (120 mg) and perform a cycling performance test. This trial will help assess the effects of a lower dose of the medication on performance.

Changes in physiological parameters such as cardiovascular and metabolic responses will be monitored during the 90-minute cycling simulation.

5 full-dose trial

Participants will ingest a full dose of pseudoephedrine (240 mg) and perform another cycling performance test. This trial aims to evaluate the effects of the full dose on endurance performance.

The study will measure changes in time trial duration, average power output, and physiological parameters compared to the placebo and half-dose trials.

6 sample collection

Throughout the trials, samples of blood and urine will be collected to measure the concentration of pseudoephedrine. Various methods such as venipuncture and urine collection will be used.

These samples will help determine the threshold values of the medication in the body and assess its impact on performance.

7 final assessment

At the end of the study, participants will undergo a final assessment to evaluate any changes in their physical performance and physiological parameters.

The results from this assessment will be compared with the baseline measurements to determine the effects of pseudoephedrine on endurance performance.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitair Ziekenhuis Gent	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	27.05.2025

Trial locations

Investigated drugs:

Lactose Monohydrate

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.

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 ID:

2024-513810-36-00

Protocol code:

ONZ-2023-0546

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Pseudoephedrine on Cycling Performance in Healthy Volunteers

What is this study about?

Who Can Join the Study?

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