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AttentionHECOGNCT07405632

The Impact of Supplementation With Hericium Erinaceus (Lion's Mane) Extract on Cognitive Functioning

A study testing Hericium erinaceus Supplementation in people with Attention and Memory, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.

Completed

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

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 50 years, women onlyHealthy volunteers can take part
What is being tested?
Hericium erinaceus Supplementation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
1 sitePoland
Study dates
13 Jan 2025to 11 Oct 2025
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 30 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • residing in Warsaw, Poland or the surrounding area.

Who cannot join

  • pregnancy or lactation,
  • history of head injury with neurological consequences,
  • history of neurological disorders or diseases,
  • chronic use of antibiotics,
  • use of antibiotics within the last 30 days,
  • chronic use of antifungal medications,
Show all 9Show fewer
  • use of antifungal medications within the last 30 days,
  • allergies or intolerance to mushrooms (especially Lion's Mane),
  • consumption of caffeinated beverages (e.g., coffee, energy drinks) prior to the study visit.

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • SWPS University

    Warsaw, Masovian Voivodeship, 03-815

Other trials in Poland

About this study

Official title: The Impact of Supplementation With Hericium Erinaceus (Lion's Mane) Extract on Cognitive Functioning: A Double-blind Placebo-controlled Study

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:

Read more
  1. Can Hericium erinaceus extract supplementation modify cognitive status?
  2. Is there an immediate effect on cognition following a single intake of Hericium erinaceus extract?
  3. Does prolonged supplementation with Hericium erinaceus extract influence cognitive functioning?
  4. Which cognitive functions are affected, and will the patterns differ between immediate effects and those observed after long-term supplementation?
  5. Will participants report subjective cognitive enhancement?

Our main hypotheses are as follows:

  1. A single dose of Hericium erinaceus extract will produce an acute effect, improving attention 45 minutes after intake.
  2. An eight-week supplementation period with Hericium erinaceus extract will produce a chronic effect, improving long-term memory.
  3. The investigators will compare Hericium erinaceus extract with a placebo (a visually identical substance that contains no active ingredients) to determine whether the extract effectively enhances cognitive functioning.

Participants will:

  1. Take a Hericium erinaceus extract or placebo capsule daily for 2 months.
  2. Visit SWPS University for baseline assessments before beginning supplementation (T0), a follow-up assessment 45 minutes after the initial intake (T1), and additional assessments at 1 week (T2) and 2 months (T3).
  3. Complete neuropsychological testing and questionnaires during the T1, T2, and T3 visits.
  4. Maintain their usual dietary habits throughout the study.
Being tested
Hericium erinaceus Supplementation, Placebo
Keywords
Lion's Mane, Hericium erinaceus, Cognitive functioning, Attention, Well-being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hericium erinaceus SupplementationDietary supplement

    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.*

  • PlaceboDietary supplement

    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.*

Study groups in NCT07405632
Study groupRoleWhat they receive
Hericium erinaceuExperimentalThis is a group of participants who will receive Hericium erinaceu during the duration of the study.
Receives: Dietary Supplement: Hericium erinaceus Supplementation
PlaceboPlacebo comparatorThis is a group of participants who will receive placebo during the wole duration of the study.
Receives: Dietary Supplement: Placebo

What is being measured

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

  1. 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

    Measured: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

  2. 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.

    Measured: 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

  3. 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.

    Measured: 45 minutes after the first dose, and at 8 week after the start of supplementation with Hericium erinaceus extract or placebo.

  4. 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.

    Measured: 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

  5. 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.

    Measured: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

  6. 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.

    Measured: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

Secondary outcomes (10)
  1. 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.

    Measured: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

  2. 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.

    Measured: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

  3. 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.

    Measured: 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

  4. 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.

    Measured: 45 minutes after the first dose, and at 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

  5. 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.

    Measured: 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.

  6. 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.

    Measured: 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.

  7. 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.

    Measured: 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.

  8. 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.

    Measured: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

  9. 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.

    Measured: 45 minutes after the first dose, and at 1 week and 8 weeks after the start of supplementation with Hericium erinaceus extract or placebo.

  10. Change in energy scores

    Scores range from 0 to 100, with higher scores indicating higher subjective energy at the time of assessment.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start13 Jan 2025
  3. Primary completion11 Oct 2025
  4. Study completion11 Oct 2025

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
Model description
Randomized, double-blind, and placebo-controlled study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07405632
Sponsor's protocol ID
Hericium erinaceus - Cognition
Other IDs
GW2
Acronym
HECOG
Status last verified
Feb 2026
First submitted
26 Jan 2026
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Hericium erinaceus Supplementation in people with Attention and Memory, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.

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 1 inclusion and 9 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 12 Feb 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 Poland. 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. Some participants in this study may receive a placebo. 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?

Change in d' score in old/new recognition test (ONR) to assess long-term memory (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.). The study lists 6 primary outcomes in all. 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 12 Feb 2026.

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