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NCT Number: NCT07359534

Training Health Recovery and Improvement Via Levagen+® Evaluation

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.

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Key information

Conditions

Exercise Recovery Dyssomnias Inflammation Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Westminster London

London, W1W 6UW, United Kingdom

Location status: Recruiting

Location contact

Gulshanara (Rumy) Begum, PhD

SUB_INVESTIGATOR

Helena Tiekou Lorinczova, PhD

CONTACT

[email protected]

Helena Tiekou Lorinczova, PhD

SUB_INVESTIGATOR

Marta M Gámez-Fernández, PhD

SUB_INVESTIGATOR

Mohammed Gulrez Zariwala, PhD

PRINCIPAL_INVESTIGATOR

Sanjoy Deb, PhD

SUB_INVESTIGATOR

Victoria G Linsley, PhD

SUB_INVESTIGATOR

Vinood B Patel, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    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)

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

    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)

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

    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.

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

    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)

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

    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

  1. Changes in exercise-associated oxidative stress markers associated with intensified training in PEA supplemented athletes

    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)

  2. Changes in exercise-associated oxidative stress markers associated with intensified training in PEA supplemented athletes

    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)

  3. Changes in stress hormone levels associated with intensified training in PEA supplemented athletes

    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)

  4. Changes in stress hormone levels associated with intensified training in PEA supplemented athletes

    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)

  5. Changes in neurotrophic factor levels in PEA supplemented athletes

    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)

  6. Perceptions of muscle pain associated with intensified training in PEA supplemented athletes

    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)

  7. Changes in state and profile of perceived mood during intensified training and recovery phase using questionnaires.

    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.

  8. Perceptions of exercise-associated pleasure during endurance cycling (40km time trial) in PEA supplemented athletes

    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").

  9. Incidence and frequency of Levagen+® associated-gastrointestinal symptoms

    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).

  10. Metabolic changes following intensified training during cycling tests in PEA supplemented athletes

    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)

  11. Metabolic changes following intensified training during cycling tests in PEA supplemented athletes

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Helena Tiekou Lorinczova, PhD

CONTACT

[email protected]

Mohammed Gulrez Zariwala, PhD

CONTACT

[email protected]

0044 (0)20 7911 5000 ext. 65086

Sponsors and collaborators

Lead sponsor

University of Westminster

Other

Collaborators

  • Anglia Ruskin University

Registry information

Official study title

Recovery Following a Prolonged Period of Intensified Exercise Training: Evaluating the Impact of Levagen+® on Alleviating Physical, Physiological and Psychological Stress.

Acronym: THRIVE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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