Clinical trial NCT06225440: Impact of Levagen+® Palmitoylethanolamide (PEA) in a Cross-Over Trial Examining Stress and Cognition in University Students
Official title: The Effect of Levagen+® Palmitoylethanolamide (PEA) Supplementation on Parameters of Stress, Wellbeing and Cognition in University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wellness, Psychological
Well-Being, Psychological
Keywords: nutraceutical
palmitoylethanolamide
PEA
cognition
stress
inflammation
wellness
well-being
BDNF
supplement
Lead sponsor: University of Westminster
Sponsor class: OTHER
Collaborators: name: Gencor Pacific Group
First posted: 2024-01-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the influence of PEA supplementation on the perceived difficulties of test execution.
timeFrame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
measure: To assess the influence of PEA supplementation on the reaction and movement speed and attention.
timeFrame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
measure: To assess the influence of PEA supplementation on visual and episodic memory and visuospatial associative learning.
timeFrame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
measure: To assess the influence of PEA supplementation on short-term and spatial working memory and problem solving.
timeFrame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
measure: To assess the influence of PEA supplementation on visual processing, recognition, and sustained attention.
timeFrame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
measure: To assess the influence of PEA supplementation on Serum Brain-derived neurotrophic factor (BDNF) levels.
timeFrame: 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:
measure: To assess the influence of PEA supplementation on HRV in female population.
timeFrame: 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.
measure: To study the influence of PEA supplementation on the degree of perceived stress in females.
timeFrame: 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.
measure: To study the influence of PEA supplementation on perceived emotions in females.
timeFrame: 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.
measure: To study the influence of PEA supplementation on well-being in females.
timeFrame: 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.
measure: To assess the influence of PEA supplementation on parameters of inflammation.
timeFrame: The parameters were measured at the baseline visit (day 1) and at the endpoint visit (day 42) of the 6-week supplementation period.
measure: To assess the influence of PEA supplementation on Salivary Cortisol
timeFrame: The parameters were measured in morning and afternoon samples collected over 3 continuous days following the baseline visit (day 1, day 2 and day 3) and 3 continuous days following the endpoint visit (day 42, day 43 and day 44) of the study period.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University of Westminster
Study officials:
affiliation: University of Westminster
name: Mohammed Gulrez Zariwala, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anglia Ruskin University
name: Sanjoy Deb, PhD
role: PRINCIPAL_INVESTIGATOR
References: