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

University of Westminster

Status: Completed

Conditions: Wellness, Psychological; Well-Being, Psychological

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Levagen+® Palmitoylethanolamide (PEA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06225440

ETH2122-1031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Levagen+® Palmitoylethanolamide (PEA)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Levagen+® Palmitoylethanolamide (PEA)

Placebo

Placebo Comparator group

Description:

Placebo - Microcrystalline Cellulose

Treatment:

Dietary Supplement: Placebo