Levagen+® Palmitoylethanolamide (PEA)
Participants were instructed to consume 1 opaque capsule (350 mg Levagen+®, not less than 300mg PEA) with water daily at the same time of the day for 45 days.
Loading study record…
Loading study record…
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-01-22
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
Participants were instructed to consume 1 opaque capsule (350 mg Levagen+®, not less than 300mg PEA) with water daily at the same time of the day for 45 days.
Participants were instructed to consume 1 opaque capsule (Microcrystalline Cellulose) with water daily at the same time of the day for 45 days.
Eligibility
primary outcomes
Time frame: The parameters will be measured before the 40km cycling time trial and every 10km during the trial (overall completion time will also be recorded) on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43), endpoint forth visit (Day45)
The duration of completing the 40 km cycling time trial (hh:mm:ss)
Time frame: The parameters will be measured before the 40km cycling time trial and every 10km during the trial (overall completion time will also be recorded) on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43), endpoint forth visit (Day45)
Perceptions of exertion (RPE: Borg 6-20 scale, where 6 equals no exertion and 20 equals maximal exertion)
Time frame: Questionnaires collected daily between days 33 and 45 (inclusive)
Hooper and MacKinnon Questionnaire: a subjective assessment of the impact of DOMS in the domains of fatigue, sleep quality, general muscle soreness, stress level, and mood on a scale of 1-7, with higher scores denoting the worst results.
Time frame: The parameters will be measured before and immediately after exercise on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43) and endpoint forth visit (Day 45)
Interleukin-6 (pg/mL)
Time frame: The parameters will be measured before and immediately after exercise on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43) and endpoint forth visit (Day 45)
Tumour necrosis factor-alpha (pg/mL)
secondary outcomes
Time frame: The parameters will be measured before and immediately after exercise on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43) and endpoint forth visit (Day 45)
Tbars (µM)
Time frame: The parameters will be measured before and immediately after exercise on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43) and endpoint forth visit (Day 45)
F2-Isoprostane (pg/ml)
Time frame: The parameters will be measured before and immediately after exercise on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43) and endpoint forth visit (Day 45)
Cortisol (nmol/l)
Time frame: The parameters will be measured before and immediately after exercise on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43) and endpoint forth visit (Day 45)
Testosterone (nmol/L)
Time frame: The parameters will be measured before and immediately after exercise on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43) and endpoint forth visit (Day 45)
Brain-Derived Neurotrophic Factor (pg/ml)
Time frame: The parameters will be measured immediately before and immediately after exercise on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43) and endpoint forth visit (Day 45)
Visual Analogue Scale; scores range from 0 to 100 (the higher the score the greater the level of perceived pain)
Time frame: Questionnaires collected daily between days 33 and 45 (inclusive)
Profile of Mood States (POMS) Questionnaire: a psychological assessment comprising forty questions. The forty items yield scores on six factors: Tension, Depression (depressed mood), Anger, Vigour, Fatigue, and Confusion. The responses are evaluated on five-point response scales ranging from 0 to 4, where 0 represents the 'lack of' and 4 represents the 'most extreme' experience of a particular feeling.
Time frame: Perceived pleasure will be assessed immediately before the 40km time trial and every 10km during the trial, on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43) and endpoint forth visit (Day 45)
Felt Arousal Scale: a 6-point Likert scale measuring arousal from 1 ("low arousal" to 6 ("high arousal").
Time frame: gastrointestinal symptoms analysed daily during the supplementation period between days 33 and 45 (inclusive)
Subjective analysis using the Gastrointestinal Symptoms Rating Scale (GSRS, on a 1 to 7 Likert scale, where 1 = no discomfort, 7 = very severe discomfort).
Time frame: The parameters will be measured before the 40km cycling time trial and every 10km during the trial (overall completion time will also be recorded) on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43), endpoint forth visit (Day 45)
Blood glucose concentration (mmol/L)
Time frame: The parameters will be measured before the 40km cycling time trial and every 10km during the trial (overall completion time will also be recorded) on baseline first visit (Day 0), second visit (Day 35), third visit (Day 43), endpoint forth visit (Day 45)
Blood lactate concentration (mmol/L)
Publications