Training Health Recovery and Improvement Via Levagen+® Evaluation

NCT07359534 | Recruiting

• 1 other identifier: ETH2425-1214
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise Recovery

Keywords

nutraceutical; exercise recovery; sport; cycling; inflammation; muscle recovery; sleep quality; Palmitoylethanolamide

Outcome Measures

Primary Outcomes (5)

• 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)

  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)

  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.

  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)

  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)

  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

  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

  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

  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

  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

  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)

Study Arms (2)

Levagen+® Palmitoylethanolamide (PEA)

ACTIVE COMPARATOR

Levagen+® Palmitoylethanolamide (PEA) - 350mg/day, containing not less than 300 mg PEA

Dietary Supplement: Levagen+® Palmitoylethanolamide (PEA)

Placebo

PLACEBO COMPARATOR

Placebo - Microcrystalline Cellulose

Dietary Supplement: Placebo

Interventions

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.

Levagen+® Palmitoylethanolamide (PEA)

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: male and female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Westminster: lead
• Anglia Ruskin University: collaborator

Study Sites (1)

University of Westminster London

London, W1W 6UW, United Kingdom

RECRUITING

Related Publications (12)

• 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

  BACKGROUND

• 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.

  PMID: 27710149 BACKGROUND

• Mallard 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.

  PMID: 32106527 BACKGROUND

• LoVerme 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.

  PMID: 15963531 BACKGROUND

• Konopka 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.

  PMID: 24508740 BACKGROUND

• Kim 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.

  PMID: 38398813 BACKGROUND

• Killer 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.

  PMID: 26406911 BACKGROUND

• Kasper 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.

  PMID: 32732454 BACKGROUND

• Keppel 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.

  PMID: 24066256 BACKGROUND

• Hellsten Y, Nyberg M. Cardiovascular Adaptations to Exercise Training. Compr Physiol. 2015 Dec 15;6(1):1-32. doi: 10.1002/cphy.c140080.

  PMID: 26756625 BACKGROUND

• Gabrielsson 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.

  PMID: 27220803 BACKGROUND

• Evangelista 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.

  PMID: 29676237 BACKGROUND

MeSH Terms

Conditions

Inflammation; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mohammed Gulrez Zariwala, PhD

  University of Westminster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Gulrez Zariwala, PhD

CONTACT

0044 (0)20 7911 5000; m.zariwala@westminster.ac.uk

Helena Tiekou Lorinczova, PhD

CONTACT

h.tiekoulorinczova1@westminster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Physiology

Model Details: double-blind, randomised

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 22, 2026
• Study Start: March 10, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)