Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06225440
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2024-01-03
Brief Title:
Impact of Levagen Palmitoylethanolamide PEA in a Cross-Over Trial Examining Stress and Cognition in University Students
Sponsor:
University of Westminster
Organization:
University of Westminster
Study Overview
Official Title:
The Effect of Levagen Palmitoylethanolamide PEA Supplementation on Parameters of Stress Wellbeing and Cognition in University Students
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPRESS
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None