Exercise RecoveryTHRIVENCT07359534
Training Health Recovery and Improvement Via Levagen+® Evaluation
A study testing Levagen+® Palmitoylethanolamide (PEA) in people with Exercise Recovery, run by University of Westminster at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Recovery
- What is being tested?
- Levagen+® Palmitoylethanolamide (PEA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Mar 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- <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
Show all 9Show fewer
- Smokers
- Gastrointestinal disorders
- Eating disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Helena Tiekou Lorinczova, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Westminster London
London, W1W 6UW
Helena Tiekou Lorinczova, PhD, h.tiekoulorinczova1@westminster.ac.uk
Mohammed Gulrez Zariwala, PhD
About this study
Official title: Recovery Following a Prolonged Period of Intensified Exercise Training: Evaluating the Impact of Levagen+® on Alleviating Physical, Physiological and Psychological Stress.
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.
Read more
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.
Read the detailed 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.
- Conditions
- Exercise Recovery
- Being tested
- Levagen+® Palmitoylethanolamide (PEA), Placebo
- Keywords
- nutraceutical, exercise recovery, sport, cycling, inflammation, muscle recovery, sleep quality, Palmitoylethanolamide
- Medical subject headings
- Inflammation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
Participants were instructed to consume 1 opaque capsule (Microcrystalline Cellulose) with water daily at the same time of the day for 45 days.
| Study group | Role | What they receive |
|---|---|---|
| Levagen+® Palmitoylethanolamide (PEA) | Active comparator | Levagen+® Palmitoylethanolamide (PEA) - 350mg/day, containing not less than 300 mg PEA Receives: Dietary Supplement: Levagen+® Palmitoylethanolamide (PEA) |
| Placebo | Placebo comparator | Placebo - Microcrystalline Cellulose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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)
Measured: 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)
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.
Measured: Questionnaires collected daily between days 33 and 45 (inclusive)
Changes in exercise-associated inflammatory markers associated with intensified training in PEA supplemented athletes
Interleukin-6 (pg/mL)
Measured: 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)
Changes in exercise-associated inflammatory markers associated with intensified training in PEA supplemented athletes
Tumour necrosis factor-alpha (pg/mL)
Measured: 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)
Secondary outcomes (11)
Changes in exercise-associated oxidative stress markers associated with intensified training in PEA supplemented athletes
Tbars (µM)
Measured: 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)
Changes in exercise-associated oxidative stress markers associated with intensified training in PEA supplemented athletes
F2-Isoprostane (pg/ml)
Measured: 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)
Changes in stress hormone levels associated with intensified training in PEA supplemented athletes
Cortisol (nmol/l)
Measured: 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)
Changes in stress hormone levels associated with intensified training in PEA supplemented athletes
Testosterone (nmol/L)
Measured: 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)
Changes in neurotrophic factor levels in PEA supplemented athletes
Brain-Derived Neurotrophic Factor (pg/ml)
Measured: 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)
Perceptions of muscle pain associated with intensified training in PEA supplemented athletes
Visual Analogue Scale; scores range from 0 to 100 (the higher the score the greater the level of perceived pain)
Measured: 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)
Changes in state and profile of perceived mood during intensified training and recovery phase using questionnaires.
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.
Measured: Questionnaires collected daily between days 33 and 45 (inclusive)
Perceptions of exercise-associated pleasure during endurance cycling (40km time trial) in PEA supplemented athletes
Felt Arousal Scale: a 6-point Likert scale measuring arousal from 1 ("low arousal" to 6 ("high arousal").
Measured: 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)
Incidence and frequency of Levagen+® associated-gastrointestinal symptoms
Subjective analysis using the Gastrointestinal Symptoms Rating Scale (GSRS, on a 1 to 7 Likert scale, where 1 = no discomfort, 7 = very severe discomfort).
Measured: gastrointestinal symptoms analysed daily during the supplementation period between days 33 and 45 (inclusive)
Metabolic changes following intensified training during cycling tests in PEA supplemented athletes
Blood glucose concentration (mmol/L)
Measured: 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)
Metabolic changes following intensified training during cycling tests in PEA supplemented athletes
Blood lactate concentration (mmol/L)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start10 Mar 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Exercise RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blind, randomised
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Westminster
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University
- Responsible party
- Principal investigator, Mohammed Gulrez Zariwala, University of Westminster
- Investigators
- Mohammed Gulrez Zariwala, PhD, Principal investigator, University of Westminster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359534
- Sponsor's protocol ID
- ETH2425-1214
- Acronym
- THRIVE
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nerys Williams, The Borg Rating of Perceived Exertion (RPE) scale, Occupational Medicine, Volume 67, Issue 5, July 2017, Pages 404-405, https://doi.org/10.1093/occmed/kqx063
J Wadley A, S Svendsen I, Gleeson M. Heightened Exercise-Induced Oxidative Stress at Simulated Moderate Level Altitude vs. Sea Level in Trained Cyclists. Int J Sport Nutr Exerc Metab. 2017 Apr;27(2):97-104. doi: 10.1123/ijsnem.2015-0345. Epub 2016 Oct 6.
PubMed 27710149Mallard A, Briskey D, Richards A, Mills D, Rao A. The Effect of Orally Dosed Levagen+ (palmitoylethanolamide) on Exercise Recovery in Healthy Males-A Double-Blind, Randomized, Placebo-Controlled Study. Nutrients. 2020 Feb 25;12(3):596. doi: 10.3390/nu12030596.
PubMed 32106527LoVerme J, La Rana G, Russo R, Calignano A, Piomelli D. The search for the palmitoylethanolamide receptor. Life Sci. 2005 Aug 19;77(14):1685-98. doi: 10.1016/j.lfs.2005.05.012.
PubMed 15963531Konopka AR, Harber MP. Skeletal muscle hypertrophy after aerobic exercise training. Exerc Sport Sci Rev. 2014 Apr;42(2):53-61. doi: 10.1249/JES.0000000000000007.
PubMed 24508740Kim N, Parolin B, Renshaw D, Deb SK, Zariwala MG. Formulated Palmitoylethanolamide Supplementation Improves Parameters of Cognitive Function and BDNF Levels in Young, Healthy Adults: A Randomised Cross-Over Trial. Nutrients. 2024 Feb 8;16(4):489. doi: 10.3390/nu16040489.
PubMed 38398813Killer SC, Svendsen IS, Jeukendrup AE, Gleeson M. Evidence of disturbed sleep and mood state in well-trained athletes during short-term intensified training with and without a high carbohydrate nutritional intervention. J Sports Sci. 2017 Jul;35(14):1402-1410. doi: 10.1080/02640414.2015.1085589. Epub 2015 Sep 25.
PubMed 26406911Kasper AM, Sparks SA, Hooks M, Skeer M, Webb B, Nia H, Morton JP, Close GL. High Prevalence of Cannabidiol Use Within Male Professional Rugby Union and League Players: A Quest for Pain Relief and Enhanced Recovery. Int J Sport Nutr Exerc Metab. 2020 Sep 1;30(5):315-322. doi: 10.1123/ijsnem.2020-0151. Epub 2020 Jul 30.
PubMed 32732454Keppel Hesselink JM, de Boer T, Witkamp RF. Palmitoylethanolamide: A Natural Body-Own Anti-Inflammatory Agent, Effective and Safe against Influenza and Common Cold. Int J Inflam. 2013;2013:151028. doi: 10.1155/2013/151028. Epub 2013 Aug 27.
PubMed 24066256Hellsten Y, Nyberg M. Cardiovascular Adaptations to Exercise Training. Compr Physiol. 2015 Dec 15;6(1):1-32. doi: 10.1002/cphy.c140080.
PubMed 26756625Gabrielsson L, Mattsson S, Fowler CJ. Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy. Br J Clin Pharmacol. 2016 Oct;82(4):932-42. doi: 10.1111/bcp.13020. Epub 2016 Jun 29.
PubMed 27220803Evangelista M, Cilli, De Vitis R, Militerno A, Fanfani F. Ultra-micronized Palmitoylethanolamide Effects on Sleep-wake Rhythm and Neuropathic Pain Phenotypes in Patients with Carpal Tunnel Syndrome: An Open-label, Randomized Controlled Study. CNS Neurol Disord Drug Targets. 2018;17(4):291-298. doi: 10.2174/1871527317666180420143830.
PubMed 29676237
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Following a Prolonged Period of Intensified Exercise Training: Evaluating the Impact of Levagen+® on Alleviating Physical, Physiological and Psychological Stress.
- ClinicalTrials.gov ID
- NCT07359534
- Acronym / sponsor ID
- THRIVE / ETH2425-1214
- Conditions
- Exercise Recovery
- Keywords
- nutraceutical, exercise recovery, sport, cycling, inflammation, muscle recovery, sleep quality, Palmitoylethanolamide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WestminsterUniversity, hospital or other
- Collaborators
- Anglia Ruskin University
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind, randomised
| Arm | Type | Receives |
|---|---|---|
| Levagen+® Palmitoylethanolamide (PEA) | Active comparator | Dietary Supplement: Levagen+® Palmitoylethanolamide (PEA)Levagen+® Palmitoylethanolamide (PEA) - 350mg/day, containing not less than 300 mg PEA |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo - Microcrystalline Cellulose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- <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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Levagen+® Palmitoylethanolamide (PEA) |
| PlaceboParticipants were instructed to consume 1 opaque capsule (Microcrystalline Cellulose) with water daily at the same time of the day for 45 days. | Dietary supplement | Placebo |
Primary outcome
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)
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)
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.
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)
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)
11 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
Incidence and frequency of Levagen+® associated-gastrointestinal symptoms
Time frame: gastrointestinal symptoms analysed daily during the supplementation period between days 33 and 45 (inclusive)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- BackgroundNerys Williams, The Borg Rating of Perceived Exertion (RPE) scale, Occupational Medicine, Volume 67, Issue 5, July 2017, Pages 404-405, https://doi.org/10.1093/occmed/kqx063
- Background: PubMed 27710149J Wadley A, S Svendsen I, Gleeson M. Heightened Exercise-Induced Oxidative Stress at Simulated Moderate Level Altitude vs. Sea Level in Trained Cyclists. Int J Sport Nutr Exerc Metab. 2017 Apr;27(2):97-104. doi: 10.1123/ijsnem.2015-0345. Epub 2016 Oct 6.
- Background: PubMed 32106527Mallard A, Briskey D, Richards A, Mills D, Rao A. The Effect of Orally Dosed Levagen+ (palmitoylethanolamide) on Exercise Recovery in Healthy Males-A Double-Blind, Randomized, Placebo-Controlled Study. Nutrients. 2020 Feb 25;12(3):596. doi: 10.3390/nu12030596.
- Background: PubMed 15963531LoVerme J, La Rana G, Russo R, Calignano A, Piomelli D. The search for the palmitoylethanolamide receptor. Life Sci. 2005 Aug 19;77(14):1685-98. doi: 10.1016/j.lfs.2005.05.012.
- Background: PubMed 24508740Konopka AR, Harber MP. Skeletal muscle hypertrophy after aerobic exercise training. Exerc Sport Sci Rev. 2014 Apr;42(2):53-61. doi: 10.1249/JES.0000000000000007.
- Background: PubMed 38398813Kim N, Parolin B, Renshaw D, Deb SK, Zariwala MG. Formulated Palmitoylethanolamide Supplementation Improves Parameters of Cognitive Function and BDNF Levels in Young, Healthy Adults: A Randomised Cross-Over Trial. Nutrients. 2024 Feb 8;16(4):489. doi: 10.3390/nu16040489.
- Background: PubMed 26406911Killer SC, Svendsen IS, Jeukendrup AE, Gleeson M. Evidence of disturbed sleep and mood state in well-trained athletes during short-term intensified training with and without a high carbohydrate nutritional intervention. J Sports Sci. 2017 Jul;35(14):1402-1410. doi: 10.1080/02640414.2015.1085589. Epub 2015 Sep 25.
- Background: PubMed 32732454Kasper AM, Sparks SA, Hooks M, Skeer M, Webb B, Nia H, Morton JP, Close GL. High Prevalence of Cannabidiol Use Within Male Professional Rugby Union and League Players: A Quest for Pain Relief and Enhanced Recovery. Int J Sport Nutr Exerc Metab. 2020 Sep 1;30(5):315-322. doi: 10.1123/ijsnem.2020-0151. Epub 2020 Jul 30.
- Background: PubMed 24066256Keppel Hesselink JM, de Boer T, Witkamp RF. Palmitoylethanolamide: A Natural Body-Own Anti-Inflammatory Agent, Effective and Safe against Influenza and Common Cold. Int J Inflam. 2013;2013:151028. doi: 10.1155/2013/151028. Epub 2013 Aug 27.
- Background: PubMed 26756625Hellsten Y, Nyberg M. Cardiovascular Adaptations to Exercise Training. Compr Physiol. 2015 Dec 15;6(1):1-32. doi: 10.1002/cphy.c140080.
- Background: PubMed 27220803Gabrielsson L, Mattsson S, Fowler CJ. Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy. Br J Clin Pharmacol. 2016 Oct;82(4):932-42. doi: 10.1111/bcp.13020. Epub 2016 Jun 29.
- Background: PubMed 29676237Evangelista M, Cilli, De Vitis R, Militerno A, Fanfani F. Ultra-micronized Palmitoylethanolamide Effects on Sleep-wake Rhythm and Neuropathic Pain Phenotypes in Patients with Carpal Tunnel Syndrome: An Open-label, Randomized Controlled Study. CNS Neurol Disord Drug Targets. 2018;17(4):291-298. doi: 10.2174/1871527317666180420143830.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helena Tiekou Lorinczova, PhD contact
Mohammed Gulrez Zariwala, PhD principal investigator
University of Westminster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levagen+® Palmitoylethanolamide (PEA) in people with Exercise Recovery, run by University of Westminster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Gulrez Zariwala, PhD (0044 (0)20 7911 5000 ext. 65086, m.zariwala@westminster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07359534, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.