NCT07359534 Training Health Recovery and Improvement Via Levagen+® Evaluation
| NCT ID | NCT07359534 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Westminster |
| Condition | Exercise Recovery |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-03-10 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
INTRODUCTION: Sports supplements and ergogenic aids are widely used for performance enhancement in recreational and professional sports. Athletes undergo intense training to improve their cardiorespiratory and muscular systems, aiming for positive adaptations. However, intensified training without appropriate dietary support can pose risks such as inadequate muscle recovery, weakened immune function, and reduced sleep quality, leading to increased susceptibility to illness and heightened physiological and psychological stress. The recent removal of cannabidiol (CBD) from the World Anti-Doping Agency (WADA) prohibited list has increased its popularity among athletes for its potential benefits on recovery and sleep. However, concerns about its safety and legality in sport persist, leading many governing bodies to caution against its use. Palmitoylethanolamide (PEA), a Generally Recognised as Safe (GRAS) supplement, exhibits anti-inflammatory effects and supports joint health. It also shows potential for stress and anxiety management, with ongoing research demonstrating this. Levagen+®, a formulated PEA, offers a safe, legal alternative to CBD, showing promise for recovery and sleep improvements. Additionally, PEA demonstrates neuroprotective and immunomodulating properties, indicating the potential benefits for athlete health, performance, and recovery. However, further research is needed to confirm Levagen+®'s efficacy as an ergogenic aid, especially in endurance sports. The aim of this trial is to explore the effects of Levagen+® supplementation on physical, physiological and psychological recovery during a prolonged period (one week) of intensified cycling training, when administered over a period of 45 days.
Eligibility Criteria
Inclusion Criteria: * Healthy subjects * Males and females (18-50 years of age) * Trained cyclists/triathletes indicated by: * Minimum functional threshold power (FTP, an indication of the highest average power output a cyclist can maintain for 60 minutes) of 2.9W/kg for males and 2.5W/kg for females * Minimum 2 years of 5 hours cycling training a week Exclusion Criteria: * \<18, \>50 years * Following a restrictive diet plan * Consumption of \>14 units of alcohol/week * Allergies to test foods/drinks * Illnesses or on medication (with a possible effect on taste and/or appetite) * Devices such as pacemakers * Smokers * Gastrointestinal disorders * Eating disorders
Contact & Investigator
Mohammed Gulrez Zariwala, PhD
PRINCIPAL INVESTIGATOR
University of Westminster
Frequently Asked Questions
Who can join the NCT07359534 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Exercise Recovery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07359534 currently recruiting?
Yes, NCT07359534 is actively recruiting participants. Contact the research team at m.zariwala@westminster.ac.uk for enrollment information.
Where is the NCT07359534 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07359534 clinical trial?
NCT07359534 is sponsored by University of Westminster. The principal investigator is Mohammed Gulrez Zariwala, PhD at University of Westminster. The trial plans to enroll 20 participants.