At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Levagen+® Palmitoylethanolamide (PEA) (supplement), Placebo (supplement)
- How long the study runs
- Study runs about 13 months (dates as stated)
- About the drug or intervention
- Levagen+® Palmitoylethanolamide (PEA) — 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 — supplement: Participants were instructed to consume 1 opaque capsule (Microcrystalline Cellulose) with water daily at the same time of the day for 45 days.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 50 Years
- Who
- All
- Number of participants
- 20
- Started
- 2025-03-10
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for exercise recovery
- • NA - 20 participants
- • INTRODUCTION: Sports supplements and ergogenic aids are widely used for performance enhancement in recreational and professional sports
Who can take part?
- • Ages 18 Years to 50 Years
- • Diagnosed with exercise recovery
Where?
- • London - University of Westminster London
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 50 Years
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓Minimum 2 years of 5 hours cycling training a week
Who cannot take part
- ✗\<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)
See the full criteria
Where Is This Study? (1 UK site)
University of Westminster London
London W1W 6UW, United Kingdom
How to Get in Touch
Mohammed Gulrez Zariwala, PhD
Sponsor contactCONTACT
Helena Tiekou Lorinczova, PhD
Sponsor contactCONTACT