An interventional study of Hericium erinaceus Supplementation and Placebo in Attention, Memory and Cognitive Function and Well-Being, sponsored by University of Social Sciences and Humanities, Warsaw. Completed at 1 site in Poland. Open to female participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by University of Social Sciences and Humanities, Warsaw · Not applicable, Interventional, and Prevention
The goal of this study is to determine whether supplementation with Hericium erinaceus (Lion's Mane) extract enhances selected cognitive functions in healthy, actively working, middle-aged women. We aim to investigate a broad spectrum of cognitive functions to identify which, if any, are affected both immediately and after prolonged supplementation with Hericium erinaceus extract.
Our main research questions are as follows:
Our main hypotheses are as follows:
Participants will:
University of Social Sciences and Humanities, Warsaw is the lead sponsor of 24 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
- residing in Warsaw, Poland or the surrounding area.
Exclusion Criteria:
This is a group of participants who will receive Hericium erinaceu during the duration of the study.
Dietary Supplement: Hericium erinaceus Supplementation
This is a group of participants who will receive placebo during the wole duration of the study.
Dietary Supplement: Placebo
Each participant will take extract from the fruiting bodies of Lion's Mane mushroom (Hericium erinaceus; trade name: Lion's Mane Focus; manufacturer: Omyu sp. z o.o., Warsaw, Poland). Composition: mineral water, food-grade ethanol \<22%, dried Lion's Mane fruiting bodies 20,000 mg. \* Dosage: 1ml per day\*. \* Instructions: Take before 1:00 PM.\*
Each participant will take placebo. Composition: mineral water, food-grade ethanol \<22%, caramel food flavouring 0.2%. \* Dosage: 1ml per day\*. \* Instructions: Take before 1:00 PM.\*
Change in d' score in old/new recognition test (ONR) to assess long-term memory
The old/new word recognition task is designed to assess episodic memory. It is consisted of two phases: a learning phase and a recognition phase. During the learning phase, participants viewed 30 pictures on the computer. In the recognition phase, participants were presented with 30 "old" and 30 "new" pictures in random order and were asked to determine whether each picture had been shown during the learning phase. To analyze episodic memory task we followed Macmillan and Creelman (2005) signal detection theory, where d' is the ability to discriminate between signal and noise (between old and new stimuli), H stands for the proportion of correct changes detected (hit rate), and F stands for the proportion of changes incorrectly reported (false alarm rate). d' = zH - zF
Time frame: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in Differentiation score in California Verbal Learning Test (CVLT) to assess long-term memory
California Verbal Learning Test (CVLT) measure the verbal learning and memory. It measures how well individuals learn and recall verbal material, assessing both short-term and long-term memory. The Differentiation score measures the ability to distinguish between correct and incorrect responses. Scores range from 0 to 16, with higher scores indicating better outcome.
Time frame: 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in Concentration score in d2 Test of Attention (d2-R) - to assess attention
Scores range from 0 to 308, with higher scores indicating better outcome.
Time frame: 45 minutes after the first dose, and at 8 week after the start of supplementation with Hericium erinaceus extract or placebo.
Change in the number of correctly marked target characters in the d2 Test of Attention (d2-R) - to assess attention.
Scores range from 0 to 308, with higher scores indicating better outcome.
Time frame: 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in cueing effect in the Posner Cueing Task to assess attentional orienting efficiency
The Posner Cueing Task assesses visuospatial selective attention, specifically the speed and efficiency of orienting attention to a cued location. To analyze this efficiency, we calculated the cueing effect. This is defined as the difference in mean reaction time between invalidly cued trials and validly cued trials (RT invalid-RT valid). A larger cueing effect indicates a higher "cost" of disengaging attention from an incorrect location and shifting it to the correct target.
Time frame: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in reaction time to validly cued targets in the Posner Cueing Task to assess attentional orienting speed
The Posner Cueing Task assesses visuospatial selective attention, specifically the speed and efficiency of orienting attention to a cued location. To assess attentional orienting speed, the primary outcome is the reaction time to the target in valid trials (where the cue correctly predicts the target location). A shorter reaction time indicates faster attentional orienting to the predicted spatial location. Reaction times are measured in milliseconds.
Time frame: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Changes in Beck Depression Inventory (BDI) total score to assess symptoms of depression
Scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
Time frame: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Changes in the Fatigue Assessment Scale (FAS) total score to assess symptoms of chronic fatigue
Scores range from 10 to 50, with higher scores indicating greater fatigue.
Time frame: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in Color Trails Test (CTT) completion time - CTT1 to assess several attention and executive functions especially perceptual tracking, sustained and divided attention
A maximum time limit of 240 seconds (4 minutes) is applied.
Time frame: 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in Color Trails Test (CTT) completion time - CTT2 to assess several attention and executive functions especially perceptual tracking, sustained and divided attention
A maximum time limit of 240 seconds (4 minutes) is applied.
Time frame: 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in Wechsler Adult Intelligence Scale (WAIS) Digit Span Forward subset total score to assess short-term auditory memory
Scores range from 0 to 14, with higher scores indicating better outcome.
Time frame: Baseline (prior to intervention), 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in Wechsler Adult Intelligence Scale (WAIS) Digit Span Backward subset total score to assess short-term auditory memory
Scores range from 0 to 14, with higher scores indicating better outcome.
Time frame: Baseline (prior to intervention), 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in Wechsler Adult Intelligence Scale (WAIS) Digit Symbol Substitution subtest total score to assess cognitive processing speed, visual-motor coordination, and sustained attention
Scores range from 0 to 39, with higher scores indicating better outcome.
Time frame: Baseline (prior to intervention), 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Changes in Memory Functioning Questionnaire (MFQ) total score
The Memory Functioning Questionnaire (MFQ) is a self-report instrument designed to assess subjective memory functioning and memory complaints. We utilized the version developed by Gilewski et al. (1990), which consists of 64 items divided into four main subscales: Frequency of Forgetting, Seriousness of Forgetting, Retrospective Functioning, and Mnemonics Usage. Higher scores on the MFQ indicate a higher level of perceived memory functioning.
Time frame: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in Operation Span (OSPAN) capacity load to assess working memory capacity
The Operation Span (OSPAN) task is a standard measure of working memory capacity, requiring participants to solve mathematical equations while simultaneously remembering a sequence of letters. The primary outcome measure is the capacity load, which represents the sum of all letters from sets that were recalled perfectly in their correct order. A higher capacity load score indicates a greater ability to maintain and manipulate information in the face of distraction, reflecting superior working memory capacity.
Time frame: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Change in energy scores
Scores range from 0 to 100, with higher scores indicating higher subjective energy at the time of assessment.
Time frame: Baseline (prior to intervention), 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.
Score in the Raven's Progressive Matrices test
The Raven's Progressive Matrices test is used to measure the level of general intelligence, understood as fluid intelligence. It is scored on a scale from 0 to 60, with higher scores indicating better outcome.
Time frame: 45 minutes after the first dose of supplementation with Hericium erinaceus extract or placebo.
Score in Adherence to the Mediterranean diet
The scale ranges from 0 to 7, with higher scores reflecting greater adherence to the Mediterranean diet.
Time frame: 45 minutes after the first dose of supplementation with Hericium erinaceus extract or placebo.
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University of Social Sciences and Humanities, Warsaw