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/Actively Recruiting
Led by University of Westminster · Updated on 2026-01-22
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
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
Training Health Recovery and Improvement Via Levagen+® Evaluation
M
Mohammed Gulrez Zariwala, PhD
H
Helena Tiekou Lorinczova, PhD
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University of Westminster
Lead Sponsor
Anglia Ruskin University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
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
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
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/27220803/University of Westminster
Lead Sponsor
Anglia Ruskin University
Collaborating Sponsor