RecruitingNAINTERVENTIONAL

Training Health Recovery and Improvement Via Levagen+® Evaluation

This study, called "Training Health Recovery and Improvement Via Levagen+® Evaluation," is investigating whether a supplement called Levagen+® can help healthy, active cyclists recover better from intense exercise. Athletes often push their bodies hard, which can lead to muscle soreness, poor sleep, and stress. While some products like CBD have been used, there are concerns about their use in sports. Levagen+® contains PEA, a naturally occurring substance that's considered safe and has shown potential for reducing swelling and supporting joint health. This research aims to see if Levagen+®, given over 45 days, can improve physical and mental recovery during a week of very hard cycling, compared to a look-alike dummy pill.

At a glance

Status

Recruiting

Phase

Sponsor

University of Westminster

Enrolment target

Start

10 Mar 2025

Estimated completion

30 Apr 2026

Exercise Recovery

What is this study about?

Many athletes, both professional and recreational, train very hard to improve their fitness. While this is great for performance, pushing too hard without proper rest and nutrition can sometimes lead to problems like muscles feeling very sore, trouble sleeping, developing a weaker immune system, and feeling stressed. Over time, these issues can increase the risk of getting sick or injured.

Recently, a substance called cannabidiol (CBD) became popular with athletes for recovery and sleep. However, there are still worries about its safety and whether it's allowed in all sports, so many sports organisations advise against using it. This is why researchers are looking into other options. One promising alternative is Palmitoylethanolamide, or PEA. This is a natural substance found in our bodies that's known to help with swelling and discomfort, and it's generally considered safe to use. Levagen+® is a specific type of PEA supplement.

This study wants to find out if taking Levagen+® for 45 days can help healthy, trained cyclists recover better during a special week of tougher-than-usual cycling training. Volunteers will either receive Levagen+® or a dummy pill (placebo). We'll be looking at things like muscle soreness, sleep quality, mood, and overall cycling performance to see if Levagen+® makes a positive difference compared to the dummy pill. The goal is to see if it can be a safe and legal way to support recovery for athletes.

Key takeaways

The study explores if Levagen+® helps athletes recover from intense exercise.
It involves healthy, regular cyclists taking a supplement or dummy pill for 45 days, twice.
Researchers will check muscle soreness, sleep, mood, and cycling performance.
Levagen+® contains PEA, a natural substance known for anti-swelling properties.
The study aims to find a safe and legal recovery aid for athletes.
Participation involves cycling tests, blood samples, and questionnaires.

Who may be eligible?

To join this study, you need to be a healthy man or woman between 18 and 50 years old. You should be an experienced cyclist or triathlete who trains regularly.

Specifically, you need to be able to cycle at a certain level of power – for men, this means an FTP (Functional Threshold Power, which shows how much power you can keep up for an hour) of at least 2.9 watts per kilogram of your body weight. For women, it's at least 2.5 watts per kilogram. You also need to have been cycling for at least two years and usually train for five hours or more each week.

There are also some reasons why you wouldn't be able to join. For example, if you're under 18 or over 50, if you have certain medical conditions like stomach problems, if you smoke, use certain medications, drink a lot of alcohol (more than 14 units a week), or have allergies to certain foods or drinks used in the study, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 50 years old?
Are you a healthy, trained cyclist or triathlete?
Do you cycle for at least 5 hours per week, and have you for 2+ years?
Do you meet the specific cycling power requirements (FTP)?
Do you avoid smoking and restrict alcohol intake?
Do you have no specific medical conditions or take medications that might affect the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be involved for a total of around 10 to 12 weeks. You'll be asked to take either the Levagen+® supplement or a dummy pill every day for 45 days. You won’t know which one you're taking, and neither will the researchers – this helps make the study fair.

After the first 45 days, you'll have a break of at least four weeks where you don't take any study supplements. Then, you'll switch over and take the other supplement (either Levagen+® if you had the dummy pill first, or the dummy pill if you had Levagen+® first) for another 45 days.

During the study, you'll need to do some cycling tests at home and visit the research facility four times. On your visits (at the beginning, after 35 days, and after 45 days of taking each supplement), you'll do a 40-kilometre cycling test. We'll also take blood samples and ask you to fill out questionnaires about things like muscle soreness, how much effort you feel you're putting in, your sleep, and your mood. You'll also be asked to increase your normal cycling training by 50% for one week at a specific point in the study.

Potential risks and benefits

Taking part in this study may offer some benefits, such as potentially experiencing improved recovery from exercise if you are given the active supplement. You would also contribute valuable information to medical science, which could help future athletes. As with any study, there could be some minor risks, such as discomfort from blood samples or the increased training period. Side effects from supplements are generally mild, but will be monitored closely. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Westminster London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Levagen+®?

Levagen+® is a supplement that contains Palmitoylethanolamide (PEA), a natural substance found in our bodies that may help with discomfort and recovery.

Will I know if I'm taking the real supplement or a dummy pill?

No, neither you nor the research team will know if you're taking Levagen+® or the dummy pill (placebo) until after the study is finished. This is to ensure fair results.

How long does the study last?

You'll be involved for about 10 to 12 weeks in total, with two periods of taking supplements separated by a break.

What kind of tests will I have to do?

You'll do cycling performance tests, give blood samples, and fill out questionnaires about your well-being, mood, and sleep.

Is this supplement safe?

PEA, the main ingredient in Levagen+®, is generally considered safe. The study will carefully monitor any effects you experience.

How to find out more

Mohammed Gulrez Zariwala, PhD

m.zariwala@westminster.ac.uk 0044 (0)20 7911 5000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.