NCT06225440

Impact of Levagen+® Palmitoylethanolamide (PEA) in a Cross-Over Trial Examining Stress and Cognition in University Students

The Effect of Levagen+® Palmitoylethanolamide (PEA) Supplementation on Parameters of Stress, Wellbeing and Cognition in University Students

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Westminster · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Wellness, Psychological
• Well-Being, Psychological

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Levagen+® Palmitoylethanolamide (PEA)	Participants were instructed to swallow 2 opaque capsules (Levagen+® - 90% of PEA) with water daily at the same time of the day for 6 weeks.
DIETARY_SUPPLEMENT	Placebo	Participants were instructed to swallow 2 opaque capsules (Microcrystalline Cellulose) with water daily at the same time of the day for 6 weeks.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-31
• Completion: 2024-01-31
• First posted: 2024-01-26
• Last updated: 2024-05-13

Locations

1 site across 1 country: United Kingdom