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

NCT07665840 | Completed DMC

• 1 other identifier: CSH150725
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 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

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

Outcome Measures

Primary Outcomes (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).

  baseline and post-intervention (week 0 and week 8)

Secondary Outcomes (8)

• Body weight

  Baseline and post intervention (week 0 and week 8)

• Height

  Baseline and post-intervention (week 0 and week 8)

• Sleep quality

  baseline and post intervention (week 0 and week 8)

• Physical activity

  baseline and post-intervention (week 0 and week 8)

• Dietary intake assessment

  Baseline and post-intervention (week 0 and week 8)

Study Arms (2)

Gummy Intervention

EXPERIMENTAL

Intervention group consumed six gummies daily for 8 weeks (180 mg L-theanine and 300 mg H. erinaceus extract)

Dietary Supplement: gummy intervention

control

NO INTERVENTION

Not receiving gummy

Interventions

gummy intervention DIETARY_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.

Gummy Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham Malaysia: lead

Study Sites (1)

University of Nottingham Malaysia

Semenyih, Malaysia

Location

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Shi Hui Cheng

  University of Nottingham Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Assistant Professor, Programme Director Bsc (Hons) Nutrition

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 24, 2026
• Study Start: October 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: June 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)