About this trial

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

This trial accepts healthy volunteers

Qualifiers

Healthy subjects

Males and females (18-50 years of age)

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

Disqualifiers

<18, >50 years

Following a restrictive diet plan

Consumption of >14 units of alcohol/week

Allergies to test foods/drinks

Trial design

Design model

Crossover

Treatments tested in this trial

Levagen+® Palmitoylethanolamide (PEA)
Dietary supplement
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.
Placebo
Dietary supplement
Participants were instructed to consume 1 opaque capsule (Microcrystalline Cellulose) with water daily at the same time of the day for 45 days.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Levagen+® Palmitoylethanolamide (PEA)Active comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exercise performance following intensified training during cycling tests in PEA supplemented athletes

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)

2

Exercise performance following intensified training during cycling tests in PEA supplemented athletes

Perceptions of exertion (RPE: Borg 6-20 scale, where 6 equals no exertion and 20 equals maximal exertion)

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)

3

Changes in levels of fatigue, quality of sleep, muscle soreness and mood during the intensified training and recovery period using questionnaires.

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

Questionnaires collected daily between days 33 and 45 (inclusive)

4

Changes in exercise-associated inflammatory markers associated with intensified training in PEA supplemented athletes

Interleukin-6 (pg/mL)

Time frame