Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID07359534

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

Led by University of Westminster · Updated on 2026-01-22

20

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Westminster

Lead Sponsor

A

Anglia Ruskin University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of Levagen+® Palmitoylethanolamide (PEA), a dietary supplement, on recovery in healthy, trained endurance cyclists during a period of intensified cycling training. The study aims to assess how Levagen+® impacts physical, physiological, and psychological stress during and after one week of increased training load. This trial follows a randomized, double-blind, crossover design to compare the supplement against a placebo. Participants will take either 350 mg of Levagen+® (containing at least 300 mg PEA) or a placebo capsule daily for 45 days. After completing the first supplementation period, a washout phase of at least four weeks occurs before switching to the other treatment. The study includes cycling tests, such as a Functional Threshold Power test at home and endurance 40 km time trials at the research facility on Days 0, 35, 43, and 45. Between Visits 2 and 3, participants increase their average training load by 50% for seven days to simulate intensified training. During the study, participants will follow their regular training routines and record details. Researchers will collect blood samples and administer questionnaires assessing muscle soreness, exertion, arousal, sleep quality, and mood. Measurements of exercise performance, fatigue, inflammatory and oxidative stress markers, and mood changes will be taken at specified visits and daily during the intensified training and recovery phase. Safety and gastrointestinal symptoms will also be monitored throughout. The total study duration for each participant includes supplementation, washout, and crossover phases.

CONDITIONS

Brief Title

Training Health Recovery and Improvement Via Levagen+® Evaluation

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy subjects
  • Males and females aged 18 to 50 years
  • Trained cyclists or triathletes with at least 2 years of cycling training averaging 5 hours per week
  • Minimum functional threshold power (FTP) of 2.9 W/kg for males and 2.5 W/kg for females
Not Eligible

You will not qualify if you...

  • Under 18 years or over 50 years
  • Following a restrictive diet plan
  • Consuming more than 14 units of alcohol per week
  • Allergies to test foods or drinks
  • Illnesses or taking medication that may affect taste or appetite
  • Having devices such as pacemakers
  • Current smokers
  • Gastrointestinal disorders
  • Eating disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - 45 days of supplementation plus 7 days of intensified training

Participants take one daily capsule of either Levagen+® Palmitoylethanolamide (PEA) or placebo for 45 days while following their regular training regime initially, followed by a 7-day intensified training period with increased exercise load.

4 visits to the research facility on Day 0, Day 35, Day 43, and Day 45

Follow-up

Duration - 3 days post intensified training

Participants complete recovery assessments on Day 43 and Day 45 following the intensified training period.

2 visits to the research facility for recovery assessments

Trial Site Locations

Total: 1 location

1

University of Westminster London

London, United Kingdom, W1W 6UW

Actively Recruiting

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Research Team

M

Mohammed Gulrez Zariwala, PhD

H

Helena Tiekou Lorinczova, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Published Research Related To This Trial

Heightened Exercise-Induced Oxidative Stress at Simulated Moderate Level Altitude vs. Sea Level in Trained Cyclists.

Alex J Wadley, Ida S Svendsen, Michael Gleeson

https://pubmed.ncbi.nlm.nih.gov/27710149

The Effect of Orally Dosed Levagen+™ (palmitoylethanolamide) on Exercise Recovery in Healthy Males-A Double-Blind, Randomized, Placebo-Controlled Study.

Alistair Mallard, David Briskey, Andrew Richards...

https://pubmed.ncbi.nlm.nih.gov/32106527

Formulated Palmitoylethanolamide Supplementation Improves Parameters of Cognitive Function and BDNF Levels in Young, Healthy Adults: A Randomised Cross-Over Trial.

Nadia Kim, Brenda Parolin, Derek Renshaw...

https://pubmed.ncbi.nlm.nih.gov/38398813

Evidence of disturbed sleep and mood state in well-trained athletes during short-term intensified training with and without a high carbohydrate nutritional intervention.

S C Killer, I S Svendsen, A E Jeukendrup...

https://pubmed.ncbi.nlm.nih.gov/26406911

High Prevalence of Cannabidiol Use Within Male Professional Rugby Union and League Players: A Quest for Pain Relief and Enhanced Recovery.

Andreas M Kasper, S Andy Sparks, Matthew Hooks...

https://pubmed.ncbi.nlm.nih.gov/32732454

Palmitoylethanolamide: A Natural Body-Own Anti-Inflammatory Agent, Effective and Safe against Influenza and Common Cold.

J M Keppel Hesselink, Tineke de Boer, Renger F Witkamp

https://pubmed.ncbi.nlm.nih.gov/24066256