NCT06225440

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

January 3, 2024

Last Update Submit

May 10, 2024

Conditions

Wellness, PsychologicalWell-Being, Psychological

Keywords

nutraceuticalpalmitoylethanolamidePEAcognitionstressinflammationwellnesswell-beingBDNFsupplement

Outcome Measures

Primary Outcomes (6)

  • To assess the influence of PEA supplementation on the perceived difficulties of test execution.

    Motor Screening Task (MOT) was used as a screening tool to indicate difficulties in test execution as part of the Core Cognition battery - CANTAB by Cambridge Cognition.

    The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.

  • To assess the influence of PEA supplementation on the reaction and movement speed and attention.

    Reaction Time (RTI) was used to measure reaction and movement speed and attention as part of the Core Cognition battery - CANTAB by Cambridge Cognition.

    The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.

  • To assess the influence of PEA supplementation on visual and episodic memory and visuospatial associative learning.

    Paired Associated Learning (PAL) was used to measure visual and episodic memory and visuospatial associative learning as part of the Core Cognition battery - CANTAB by Cambridge Cognition.

    The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.

  • To assess the influence of PEA supplementation on short-term and spatial working memory and problem solving.

    Spatial Working Memory (SWM) was used to measure short-term and spatial working memory and problem solving as part of the Core Cognition battery - CANTAB by Cambridge Cognition.

    The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.

  • To assess the influence of PEA supplementation on visual processing, recognition, and sustained attention.

    Rapid Visual Information Processing (RVP) was used to assess visual processing, recognition, and sustained attention as part of the Core Cognition battery - CANTAB by Cambridge Cognition.

    The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.

  • To assess the influence of PEA supplementation on Serum Brain-derived neurotrophic factor (BDNF) levels.

    Serum BDNF levels were measured.

    The parameters were measured at the baseline visit (day 1) and at the endpoint visit (day 42) of the 6-week supplementation period.

Secondary Outcomes (6)

  • To assess the influence of PEA supplementation on HRV in female population.

    The parameters were measured for 3 continuous days following the baseline visit (day 1, day 2 and day 3) and for 3 continuous days following the endpoint visit (day 42, day 43 and day 44) of the study period.

  • To study the influence of PEA supplementation on the degree of perceived stress in females.

    The parameters were measured for 3 continuous days following the baseline visit (day 1, day 2 and day 3) and for 3 continuous days following the endpoint visit (day 42, day 43 and day 44) of the study period.

  • To study the influence of PEA supplementation on perceived emotions in females.

    The parameters were measured for 3 continuous days following the baseline visit (day 1, day 2 and day 3) and for 3 continuous days following the endpoint visit (day 42, day 43 and day 44) of the study period.

  • To study the influence of PEA supplementation on well-being in females.

    The parameters were measured for 3 continuous days following the baseline visit (day 1, day 2 and day 3) and for 3 continuous days following the endpoint visit (day 42, day 43 and day 44) of the study period.

  • To assess the influence of PEA supplementation on parameters of inflammation.

    The parameters were measured at the baseline visit (day 1) and at the endpoint visit (day 42) of the 6-week supplementation period.

  • +1 more secondary outcomes

Study Arms (2)

Levagen+® Palmitoylethanolamide (PEA)

ACTIVE COMPARATOR

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

Dietary Supplement: Levagen+® Palmitoylethanolamide (PEA)

Placebo

PLACEBO COMPARATOR

Placebo - Microcrystalline Cellulose

Dietary Supplement: Placebo

Interventions

Levagen+® Palmitoylethanolamide (PEA)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.

Levagen+® Palmitoylethanolamide (PEA)
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Westminster

London, W1W 6UW, United Kingdom

Location

Related Publications (1)

  • Deb SK, Kim N, Parolin B, Renshaw D, Zariwala MG. The effects of formulated palmitoylethanolamide supplementation on indicators of stress and heart rate variability in female university students: a randomised cross-over trial. Front Nutr. 2025 Sep 19;12:1586409. doi: 10.3389/fnut.2025.1586409. eCollection 2025.

    PMID: 41049366DERIVED

MeSH Terms

Conditions

Psychological Well-BeingInflammation

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohammed Gulrez Zariwala, PhD

    University of Westminster

    PRINCIPAL INVESTIGATOR

  • Sanjoy Deb, PhD

    Anglia Ruskin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Translational Physiology

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 26, 2024

Study Start

September 1, 2022

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

May 13, 2024

Record last verified: 2024-05

Locations

GB(1)