Psychological StressTHEA-HEALNCT07665840
Effects of L-Theanine and Hericium Erinaceus Gummies on Psychological, Cognitive, and Sleep Quality in University Students
A study testing gummy intervention in people with Psychological Stress and Anxiety, run by University of Nottingham Malaysia at 1 site in Malaysia.
Trial summary
The THEA-HEAL Trial is an 8-week randomized controlled study investigating the effects of a daily gummy supplement containing L-theanine and Hericium erinaceus (Lion's mane mushroom) extract on stress, anxiety, cognitive performance, and sleep quality in university students in Malaysia. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Anxiety, Depression
- What is being tested?
- gummy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2025to 1 Jun 2026
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Malaysian male and female university students aged 18-25 years
- Reporting moderate levels of stress and/or anxiety
- Not regularly using cognitive-enhancing supplements in the past 3 months
Who cannot join
- Pregnancy or breastfeeding
- Presence of chronic medical conditions that could affect study outcomes
- Substance abuse or high caffeine intake (>400 mg/day)
- Current use of medications or supplements that may influence stress or cognitive function (e.g., antidepressants or nootropics) in the past 3 months
- Known allergies or hypersensitivity to L-theanine or Hericium erinaceus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of L-Theanine and Hericium Erinaceus-Enriched Gummies on Psychological, Cognitive, and Sleep Quality in University Students: An 8-Week Randomized Controlled Trial (THEA-HEAL Trial)
The THEA-HEAL Trial is an 8-week randomized controlled study investigating the effects of a daily gummy supplement containing L-theanine and Hericium erinaceus (Lion's mane mushroom) extract on stress, anxiety, cognitive performance, and sleep quality in university students in Malaysia. University life can be a stressful period associated with increased psychological distress, sleep problems, and difficulty concentrating.
In this study, eligible participants aged 18-25 years were randomly assigned to either receive the active gummy supplement or no supplementation. The intervention group consumed gummies twice daily, providing a total daily dose of 180 mg L-theanine and 300 mg H. erinaceus extract.
The main purpose of the study is to determine whether this nutraceutical combination can help reduce stress and anxiety and improve cognitive function and sleep quality compared with no supplementation. Additional outcomes include physical activity levels and dietary intake. Findings from this study may provide evidence on the potential role of functional food-based supplements in supporting mental well-being and cognitive health in young adults.
- Conditions
- Psychological Stress, Anxiety, Depression, Sleep Quality, Cognitive Performance
- Being tested
- gummy intervention
- Keywords
- L-theanine, Hericium erinaceus, Lion's mane, nutraceutical intervention, stress reduction, sleep quality, cognitive function, young adults, anxiety, depression, university students, Randomised controlled trial
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gummy interventionDietary supplement
Intervention group consumed six gummies daily for 8 weeks. Each gummy contained 30 mg of L-theanine and 50 mg of H. erinaceus extract, corresponding to a total daily intake of 180 mg L-theanine and 300 mg H. erinaceus extract.
| Study group | Role | What they receive |
|---|---|---|
| Gummy Intervention | Experimental | Intervention group consumed six gummies daily for 8 weeks (180 mg L-theanine and 300 mg H. erinaceus extract) Receives: Dietary Supplement: gummy intervention |
| control | No intervention | Not receiving gummy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological assessment
Psychological outcomes were evaluated using the 21-item Depression, Anxiety, and Stress Scale (DASS-21) Scores for each subscale range from 0 to 21, with higher scores indicating greater levels of depression, anxiety, and stress (i.e., worse psychological outcomes).
Measured: baseline and post-intervention (week 0 and week 8)
Secondary outcomes (8)
Body weight
Body weight was measured using a calibrated digital weighing scale (Inbody 230, South Korea) to the nearest 0.1 kg. Participants were instructed to remove shoes, heavy clothing, and personal items prior to measurement. Body mass index (BMI) was derived using the formula body weight (kg) divided by height squared (m2).
Measured: Baseline and post intervention (week 0 and week 8)
Height
Height was measured using a portable stadiometer (SECA 213, Germany) to the nearest 0.1 cm. Height was assessed with participants standing upright, heels together, arms relaxed at the sides, and head positioned in the Frankfort horizontal plane. Body mass index (BMI) was derived using the formula body weight (kg) divided by height squared (m2).
Measured: Baseline and post-intervention (week 0 and week 8)
Sleep quality
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The questionnaire consists of 19 self-rated items that assess seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of medication and daytime dysfunction. Each component is scored from 0 to 3, yielding a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global score >5 indicated poor sleep quality.
Measured: baseline and post intervention (week 0 and week 8)
Physical activity
Physical activity levels were assessed using the International Physical Activity Questionnaire - Short Form. The questionnaire contains seven items quantifying the frequency (days per week) and duration (minutes per day) of walking, moderate-intensity activity, vigorous-intensity activity, and sedentary behaviour.
Responses were converted into metabolic equivalent task (MET)-minutes per week according to standardized IPAQ scoring guidelines. Participants were categorized into low (<600 MET-min/week), moderate (600-3000 MET-min/week), and high (>3000 MET-min/week) physical activity levels.
Measured: baseline and post-intervention (week 0 and week 8)
Dietary intake assessment
Dietary intake was assessed using a 24-hour dietary recall method. Participants reported all food and beverage consumption over the previous 24 hours, including portion size, preparation methods, meal timing, and eating location.
Measured: Baseline and post-intervention (week 0 and week 8)
Stroop Test
Executive function and inhibitory control were assessed using a standardized colour-word Stroop task administered in paper-based format. Participants completed a single list of incongruent colour-word stimuli and were instructed to name the ink colour while ignoring the written word. A brief practice trial was provided prior to testing. Total completion time (seconds) and number of errors were recorded, with faster completion and fewer errors indicating better performance.
Measured: baseline and post-intervention (week 0 and week 8)
Logical Location Test
Visuospatial memory was assessed using a 5 × 5 grid-based recall task adapted from established visuospatial memory paradigms. Participants were presented with a grid containing 10 everyday objects positioned in fixed locations and were given 30 seconds to memorize the arrangement. The stimulus was then removed, and participants were required to reproduce the object locations. One point was awarded for each correctly recalled location with higher score indicates better visuospatial memory
Measured: Baseline and post-intervention (week 0 and week 8)
Trail Making Test
Cognitive processing speed and mental flexibility were assessed using the standard Trail Making Test Parts A and B. The test was administered in paper-based format. In Part A, participants connected numbers in ascending order, while Part B required alternating between numbers and letters. Time to completion (seconds) was recorded. Errors were corrected immediately, and timing continued until completion.
Measured: Baseline and post-intervention (week 0 and week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Oct 2025
- Primary completion30 Apr 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Hui Cheng, University of Nottingham Malaysia
- Investigators
- Shi Hui Cheng, Principal investigator, University of Nottingham Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665840
- Sponsor's protocol ID
- CSH150725
- Acronym
- THEA-HEAL
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of L-Theanine and Hericium Erinaceus-Enriched Gummies on Psychological, Cognitive, and Sleep Quality in University Students: An 8-Week Randomized Controlled Trial (THEA-HEAL Trial)
- ClinicalTrials.gov ID
- NCT07665840
- Acronym / sponsor ID
- THEA-HEAL / CSH150725
- Conditions
- Psychological Stress, Anxiety, Depression, Sleep Quality, Cognitive Performance
- Keywords
- L-theanine, Hericium erinaceus, Lion's mane, nutraceutical intervention, stress reduction, sleep quality, cognitive function, young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of Nottingham MalaysiaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 24 Jun 2026 (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 THEA-HEAL Trial is an 8-week randomized controlled study investigating the effects of a daily gummy supplement containing L-theanine and Hericium erinaceus (Lion's mane mushroom) extract on stress, anxiety, cognitive performance, and sleep quality in university students in Malaysia. University life can be a stressful period associated with increased psychological distress, sleep problems, and difficulty concentrating.
In this study, eligible participants aged 18-25 years were randomly assigned to either receive the active gummy supplement or no supplementation. The intervention group consumed gummies twice daily, providing a total daily dose of 180 mg L-theanine and 300 mg H. erinaceus extract.
The main purpose of the study is to determine whether this nutraceutical combination can help reduce stress and anxiety and improve cognitive function and sleep quality compared with no supplementation. Additional outcomes include physical activity levels and dietary intake. Findings from this study may provide evidence on the potential role of functional food-based supplements in supporting mental well-being and cognitive health in young adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gummy Intervention | Experimental | Dietary Supplement: gummy interventionIntervention group consumed six gummies daily for 8 weeks (180 mg L-theanine and 300 mg H. erinaceus extract) |
| control | No intervention | –Not receiving gummy |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Malaysian male and female university students aged 18-25 years
- Reporting moderate levels of stress and/or anxiety
- Not regularly using cognitive-enhancing supplements in the past 3 months
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding
- Presence of chronic medical conditions that could affect study outcomes
- Substance abuse or high caffeine intake (>400 mg/day)
- Current use of medications or supplements that may influence stress or cognitive function (e.g., antidepressants or nootropics) in the past 3 months
- Known allergies or hypersensitivity to L-theanine or Hericium erinaceus
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 |
|---|---|---|
| gummy interventionIntervention group consumed six gummies daily for 8 weeks. Each gummy contained 30 mg of L-theanine and 50 mg of H. erinaceus extract, corresponding to a total daily intake of 180 mg L-theanine and 300 mg H. erinaceus extract. | Dietary supplement | Gummy Intervention |
Primary outcome
Psychological assessment
Time frame: baseline and post-intervention (week 0 and week 8)
Psychological outcomes were evaluated using the 21-item Depression, Anxiety, and Stress Scale (DASS-21) Scores for each subscale range from 0 to 21, with higher scores indicating greater levels of depression, anxiety, and stress (i.e., worse psychological outcomes).
8 secondary outcomes
Body weight
Time frame: Baseline and post intervention (week 0 and week 8)
Height
Time frame: Baseline and post-intervention (week 0 and week 8)
Sleep quality
Time frame: baseline and post intervention (week 0 and week 8)
Physical activity
Time frame: baseline and post-intervention (week 0 and week 8)
Dietary intake assessment
Time frame: Baseline and post-intervention (week 0 and week 8)
Stroop Test
Time frame: baseline and post-intervention (week 0 and week 8)
Logical Location Test
Time frame: Baseline and post-intervention (week 0 and week 8)
Trail Making Test
Time frame: Baseline and post-intervention (week 0 and week 8)
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 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Shi Hui Cheng principal investigator
University of Nottingham Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gummy intervention in people with Psychological Stress and Anxiety, run by University of Nottingham Malaysia at 1 site in Malaysia.
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 5 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 24 Jun 2026. 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 Malaysia. 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. 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?
Psychological assessment (time frame: baseline and post-intervention (week 0 and week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.