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

NCT06225440 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-05-13

No results posted yet for this study

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.

Conditions

  • Wellness, Psychological
  • Well-Being, Psychological

Interventions

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.

Sponsors & Collaborators

  • Gencor Pacific Group

    collaborator INDUSTRY

  • University of Westminster

    lead OTHER

Principal Investigators

  • Mohammed Gulrez Zariwala, PhD · University of Westminster

  • Sanjoy Deb, PhD · Anglia Ruskin University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-12-31
Completion
2024-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06225440 on ClinicalTrials.gov