Effects of L-Theanine and Hericium Erinaceus Gummies on Psychological, Cognitive, and Sleep Quality in University Students (THEA-HEAL)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Sleep Quality; Cognitive Performance; Psychological Stress
• Intervention / Treatment: Dietary supplement: gummy intervention

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Semenyih, Malaysia
    • University of Nottingham Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gummy Intervention; Intervention group consumed six gummies daily for 8 weeks (180 mg L-theanine and 300 mg H. erinaceus extract)	Dietary supplement: gummy intervention; 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.
No Intervention: control; Not receiving gummy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	baseline and post-intervention (week 0 and week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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.	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.	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.	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	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.	Baseline and post-intervention (week 0 and week 8)

Collaborators and Investigators

• Sponsor: University of Nottingham Malaysia
• Investigators: Principal Investigator: Shi Hui Cheng, University of Nottingham Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): June 1, 2026

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: depression; cognitive function; Randomised controlled trial; anxiety; stress reduction; young adults; university students; sleep quality; L-theanine; Hericium erinaceus; Lion's mane; nutraceutical intervention
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders; Stress, Psychological
• Other Study ID Numbers: CSH150725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No