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

U

University of Westminster

Status

Active, not recruiting

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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