Effects of L-Theanine and Hericium Erinaceus Gummies on Psychological, Cognitive, and Sleep Quality in University Students
NCT07665840, Not applicable, Completed, University of Nottingham Malaysia
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of L-Theanine and Hericium Erinaceus Gummies on Psychological, Cognitive, and Sleep Quality in University Students | ClinicalTrials.gov |
| NCT number | NCT07665840 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 67 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Nottingham Malaysia | ClinicalTrials.gov |
| Conditions | Psychological Stress, Anxiety, Depression, Sleep Quality, Cognitive Performance | ClinicalTrials.gov |
| Interventions | gummy intervention | ClinicalTrials.gov |
| First posted | 2026-06-24 | ClinicalTrials.gov |
| Last updated | 2026-06-24 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Psychological assessment | 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). | ClinicalTrials.gov |
| Secondary | Body weight | Baseline and post intervention (week 0 and week 8) | 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). | ClinicalTrials.gov |
| Secondary | Height | Baseline and post-intervention (week 0 and week 8) | 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). | ClinicalTrials.gov |
| Secondary | Sleep quality | baseline and post intervention (week 0 and week 8) | 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. | ClinicalTrials.gov |
| Secondary | Physical activity | baseline and post-intervention (week 0 and week 8) | 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. | ClinicalTrials.gov |
| Secondary | Dietary intake assessment | Baseline and post-intervention (week 0 and week 8) | 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. | ClinicalTrials.gov |
| Secondary | Stroop Test | baseline and post-intervention (week 0 and week 8) | 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. | ClinicalTrials.gov |
| Secondary | Logical Location Test | Baseline and post-intervention (week 0 and week 8) | 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 | ClinicalTrials.gov |
| Secondary | Trail Making Test | Baseline and post-intervention (week 0 and week 8) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)