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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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

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Wellness, Psychological Well-Being, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participants (and supplements) will be coded and randomly allocated (applied randomly by software) to treatment arms to eliminate order effects and maintain research staff blinding.

Study Groups

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Levagen+® Palmitoylethanolamide (PEA)

Levagen+® Palmitoylethanolamide (PEA) - 700mg/day, containing not less than 600 mg PEA.

Group Type ACTIVE_COMPARATOR

Levagen+® Palmitoylethanolamide (PEA)

Intervention Type DIETARY_SUPPLEMENT

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.

Placebo

Placebo - Microcrystalline Cellulose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Participants were instructed to swallow 2 opaque capsules (Microcrystalline Cellulose) with water daily at the same time of the day for 6 weeks.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Males \& Females
* 18 to 40 years of age
* Fully enrolled full-time university students from London

Exclusion Criteria

* Consumption of \>14 servings of alcohol/week
* Any learning disability (e.g. dysphasia)
* Any neurobiological disorders (e.g. autism)
* Smokers Any allergies/health issues related to items being ingested
* Any serious illnesses or those on chronic medication
* Any pregnant or lactating women
* Any woman who is trying to conceive
* Any chronic gastrointestinal disorders
* Any chronic menstrual disorders (e.g. PCOS)
* Any subjects who have undergone menopause or undergoing the perimenopause transition
* Any eating disorders
* Any depression/mental disorders
* Any obese sedentary (not physically active) individual, according to BMI values
* Any abnormal blood pressure levels
* Shift work

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes