Training Health Recovery and Improvement Via Levagen+® Evaluation

Phase

N/A

Condition

Inflammation

Treatment

Placebo

Levagen+® Palmitoylethanolamide (PEA)

Clinical Study ID

NCT07359534

ETH2425-1214

Ages 18-50
All Genders
Accepts Healthy Volunteers

Study 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

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 poweroutput a cyclist can maintain for 60 minutes) of 2.9W/kg for males and 2.5W/kg forfemales
Minimum 2 years of 5 hours cycling training a week

Exclusion

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

Study Design

Placebo

March 10, 2025

April 30, 2026

Study Description

An intervention study with two treatment groups in a randomised, double-blind, crossover design.

Study population: Healthy, trained endurance cyclists (male or female) will receive supplements (active PEA or equivalent placebos allocated randomly) daily for 45 days, followed by a minimum 4-week washout period before receiving the other intervention.

Participants will be required to complete a cycling performance test (Functional Threshold Power [FTP] test) at home the day before attending laboratory testing visits 1, 2 and 4 (Day 0, Day 35 and Day 45 of supplementation), respectively. On the baseline first visit (Day 0), second (Day 35), third (Day 43) and endpoint fourth visits (Day 45) to the research facility, participants will be requested to complete an endurance cycling test (a 40 km time trial). Blood samples and pertinent questionnaires (Visual Analogue Scale (VAS) assessing muscle soreness; questionnaires assessing perception of exertion and arousal; sleep quality, mood and oral supplementation questionnaires) will also be collected at the aforementioned time points.

Participants will be required to follow and record their regular training regime from Day 1 to Day 35 of the study. The collected data over the course of these 5 weeks will be used to establish the intensified training protocol, whereby the average training load of the participant will be increased by 50%. The intensified training protocol will be assigned to participants to be completed over a 7-day period between the second visit (Day 35) and the third visit (Day 43). Participants will visit the research facility on Day 43 and Day 45 to assess recovery on day 1 and day 3 post intensified training period.

Connect with a study center

University of Westminster London
London 2643743, W1W 6UW
United Kingdom
Active - Recruiting

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