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Clinical Trial Summary

The goal of this randomised cross-over trial is to learn about the effects of Levagen+® Palmitoylethanolamide (PEA) supplementation on cognition, wellness and well-being in young and healthy university students. The main question it aims to answer is: • Does the PEA supplementation affect parameters of stress, mood, cognition and well-being in university students? Participants will complete 2 baseline on-site visits during which they will be assigned to Levagen+® Palmitoylethanolamide (PEA) treatment or placebo arm each time and: - complete anthropometric measurements, questionnaires and surveys, - undergo blood and saliva sampling - complete a cognitive assessment (CANTAB) - a randomly chosen cohort will also measure heart rate variability (HRV) over 3 days. Researchers will compare the PEA treatment group to the placebo to see if there is a significant difference.


Clinical Trial Description

The study will investigate the effect of Levagen+® Palmitoylethanolamide (PEA) supplementation on parameters of stress, well-being and cognition at defined time points. Assessments will be made using a combination of a range of stress measures, which will include physiological and psychometric parameters. Physiological measures will include assessments of known biomarkers of the principal stress-sensitive physiological systems, the hypothalamic-pituitary-adrenal axis, and the autonomic nervous system, while psychometric measures will include established instruments to assess general health, somatic stress symptoms, academic stress, response to stress, cognition, and mood. ;


Study Design


NCT number NCT06225440
Study type Interventional
Source University of Westminster
Contact
Status Completed
Phase N/A
Start date September 1, 2022
Completion date January 31, 2024