Wellness, PsychologicalIMPRESSNCT06225440
Impact of Levagen+® Palmitoylethanolamide (PEA) in a Cross-Over Trial Examining Stress and Cognition in University Students
A study testing Levagen+® Palmitoylethanolamide (PEA) in people with Wellness, Psychological and Well-Being, Psychological, run by University of Westminster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Wellness, Psychological, Well-Being, Psychological
- What is being tested?
- Levagen+® Palmitoylethanolamide (PEA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males \& Females
- 18 to 40 years of age
- Fully enrolled full-time university students from London
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Levagen+® Palmitoylethanolamide (PEA) Supplementation on Parameters of Stress, Wellbeing and Cognition in University Students
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:
Read more
- 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.
Read the 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.
- Conditions
- Wellness, Psychological, Well-Being, Psychological
- Being tested
- Levagen+® Palmitoylethanolamide (PEA), Placebo
- Keywords
- nutraceutical, palmitoylethanolamide, PEA, cognition, stress, inflammation, wellness, well-being, BDNF, supplement
- Medical subject headings
- Psychological Well-Being, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Levagen+® Palmitoylethanolamide (PEA) | Active comparator | Levagen+® Palmitoylethanolamide (PEA) - 700mg/day, containing not less than 600 mg PEA. Receives: Dietary Supplement: Levagen+® Palmitoylethanolamide (PEA) |
| Placebo | Placebo comparator | Placebo - Microcrystalline Cellulose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
HRV was measured for 3 full days.
Measured: 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 Perceived Stress Scale (PSS) a 10-item questionnaire was used to measure the degree to which situations in the participant's life were appraised as stressful.
The questions investigate how often certain feelings and thoughts were experienced on a five-point scale from 'never' to 'very often' (never =0, almost never = 1, sometimes = 2, fairly often = 3 and very often = 4) during the 3-day observation periods. To calculate a total PSS score, responses to the four positively stated items (items 4, 5, 7 and 8) first need to be reversed (i.e. 0 => 4; 1 => 3; 2 => 2; 3 => 1; 4 => 0).
The PSS score were then obtained by summing across all items. Higher scores indicate higher levels of perceived stress.
Measured: 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 Positive and Negative Affect Schedule (PANAS) was used to assess feelings of both positive and negative emotions experienced simultaneously.
Measured: 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.
Student Well-being Process Questionnaire (WPQ) a 44-item questionnaire was used to examine predictors of positive well-being, adverse mental health, and cognitive function. The responses to questions 1 - 42 were assessed on a 10-point scale and or questions 43 and 44 on a 4-point scale. Where with outcomes related to positive well-being high scores = more positive; with outcomes related to adverse mental health high scores = more negative and with outcomes related to cognitive function high scores = more cognitive problems. Positive well-being was predicted by high positive personality, high social support and low stressor and low negative coping scores. Negative outcomes were predicted by high stressor, coping and conscientiousness scores, and low positive personality and low social support scores. Cognitive problems were predicted by high stressor and negative coping scores and low positive personality scores.
Measured: 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.
Interferon-gamma (pg/mL), Interleukin-1 beta (pg/mL), Interleukin 6 (pg/mL), Interleukin 10 (pg/mL), Tumour necrosis factor alpha (pg/mL) levels were measured.
Measured: The parameters were measured at the baseline visit (day 1) and at the endpoint visit (day 42) of the 6-week supplementation period.
To assess the influence of PEA supplementation on Salivary Cortisol
Salivary Cortisol levels were measured during morning, afternoon and evening for 3 days following each baseline and endpoint visit at home.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Sep 2022
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wellness, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Westminster
- Sponsor type
- University, hospital or other
- Collaborators
- Gencor Pacific Group
- Responsible party
- Principal investigator, Mohammed Gulrez Zariwala, University of Westminster
- Investigators
- Mohammed Gulrez Zariwala, PhD, Principal investigator, University of WestminsterSanjoy Deb, PhD, Principal investigator, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225440
- Sponsor's protocol ID
- ETH2122-1031
- Acronym
- IMPRESS
- Status last verified
- May 2024
- First submitted
- 3 Jan 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41049366
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Levagen+® Palmitoylethanolamide (PEA) Supplementation on Parameters of Stress, Wellbeing and Cognition in University Students
- ClinicalTrials.gov ID
- NCT06225440
- Acronym / sponsor ID
- IMPRESS / ETH2122-1031
- Conditions
- Wellness, Psychological, Well-Being, Psychological
- Keywords
- nutraceutical, palmitoylethanolamide, PEA, cognition, stress, inflammation, wellness, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of WestminsterUniversity, hospital or other
- Collaborators
- Gencor Pacific Group
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levagen+® Palmitoylethanolamide (PEA) | Active comparator | Dietary Supplement: Levagen+® Palmitoylethanolamide (PEA)Levagen+® Palmitoylethanolamide (PEA) - 700mg/day, containing not less than 600 mg PEA. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo - Microcrystalline Cellulose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males \& Females
- 18 to 40 years of age
- Fully enrolled full-time university students from London
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levagen+® Palmitoylethanolamide (PEA)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. | Dietary supplement | Levagen+® Palmitoylethanolamide (PEA) |
| PlaceboParticipants were instructed to swallow 2 opaque capsules (Microcrystalline Cellulose) with water daily at the same time of the day for 6 weeks. | Dietary supplement | Placebo |
Primary outcome
To assess the influence of PEA supplementation on the perceived difficulties of test execution.
Time frame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
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.
To assess the influence of PEA supplementation on the reaction and movement speed and attention.
Time frame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
Reaction Time (RTI) was used to measure reaction and movement speed and attention as part of the Core Cognition battery - CANTAB by Cambridge Cognition.
To assess the influence of PEA supplementation on visual and episodic memory and visuospatial associative learning.
Time frame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
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.
To assess the influence of PEA supplementation on short-term and spatial working memory and problem solving.
Time frame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
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.
To assess the influence of PEA supplementation on visual processing, recognition, and sustained attention.
Time frame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.
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.
To assess the influence of PEA supplementation on Serum Brain-derived neurotrophic factor (BDNF) levels.
Time frame: The parameters were measured at the baseline visit (day 1) and at the endpoint visit (day 42) of the 6-week supplementation period.
Serum BDNF levels were measured.
6 secondary outcomes
To assess the influence of PEA supplementation on HRV in female population.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The parameters were measured at the baseline visit (day 1) and at the endpoint visit (day 42) of the 6-week supplementation period.
To assess the influence of PEA supplementation on Salivary Cortisol
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 41049366Deb 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Gulrez Zariwala, PhD principal investigator
University of Westminster
Sanjoy Deb, PhD principal investigator
Anglia Ruskin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levagen+® Palmitoylethanolamide (PEA) in people with Wellness, Psychological and Well-Being, Psychological, run by University of Westminster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the influence of PEA supplementation on the perceived difficulties of test execution. (time frame: The parameters were measured during the baseline visit (day 1) and during the endpoint visit (day 42) of the 6-week supplementation period.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06225440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.