AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Malaysia1 site
  • University of Nottingham Malaysia

    Semenyih

Other trials in Malaysia

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.

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 groups in NCT07665840
Study groupRoleWhat they receive
Gummy InterventionExperimentalIntervention group consumed six gummies daily for 8 weeks (180 mg L-theanine and 300 mg H. erinaceus extract)
Receives: Dietary Supplement: gummy intervention
controlNo interventionNot receiving gummy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  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.

  1. First posted24 Jun 2026
  2. Study start1 Oct 2025
  3. Primary completion30 Apr 2026
  4. Study completion1 Jun 2026

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in