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Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
NA
NCT ID
NCT07359534

Trial 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.

Sponsor: University of Westminster
Participants: ALL
Start: 2025-03-10
Completion: 2026-03-31
Min Age: 18 Years
Max Age: 50 Years

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: * 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

Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.

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