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

NCT07405632 | Completed DMC

• 2 other identifiers: Hericium erinaceus - CognitionGW2
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Can Hericium erinaceus extract supplementation modify cognitive status?
2. 2.Is there an immediate effect on cognition following a single intake of Hericium erinaceus extract?
3. 3.Does prolonged supplementation with Hericium erinaceus extract influence cognitive functioning?
4. 4.Which cognitive functions are affected, and will the patterns differ between immediate effects and those observed after long-term supplementation?
5. 5.Will participants report subjective cognitive enhancement?
6. 6.A single dose of Hericium erinaceus extract will produce an acute effect, improving attention 45 minutes after intake.
7. 7.An eight-week supplementation period with Hericium erinaceus extract will produce a chronic effect, improving long-term memory.
8. 8.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.
9. 9.Take a Hericium erinaceus extract or placebo capsule daily for 2 months.
10. 10.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).
11. 11.Complete neuropsychological testing and questionnaires during the T1, T2, and T3 visits.
12. 12.Maintain their usual dietary habits throughout the study.

Conditions

Attention; Memory; Cognitive Function and Well-Being

Keywords

Lion's Mane; Hericium erinaceus; Cognitive functioning; Attention; Well-being

Outcome Measures

Primary Outcomes (6)

• 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

  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.

  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.

  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.

  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.

  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.

  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)

• Changes in Beck Depression Inventory (BDI) total score to assess symptoms of depression

  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

  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

  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

  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

  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.

Other Outcomes (2)

• Score in the Raven's Progressive Matrices test

  45 minutes after the first dose of supplementation with Hericium erinaceus extract or placebo.

• Score in Adherence to the Mediterranean diet

  45 minutes after the first dose of supplementation with Hericium erinaceus extract or placebo.

Study Arms (2)

Hericium erinaceu

EXPERIMENTAL

This is a group of participants who will receive Hericium erinaceu during the duration of the study.

Dietary Supplement: Hericium erinaceus Supplementation

Placebo

PLACEBO COMPARATOR

This is a group of participants who will receive placebo during the wole duration of the study.

Dietary Supplement: Placebo

Interventions

Hericium erinaceus Supplementation DIETARY_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.\*

Hericium erinaceu

Placebo DIETARY_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.\*

Placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- residing in Warsaw, Poland or the surrounding area.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• University of Social Sciences and Humanities, Warsaw: lead
• Omyu Sp. z o.o.: collaborator
• SWPS University Doctoral School: collaborator

Study Sites (1)

SWPS University

Warsaw, Masovian Voivodeship, 03-815, Poland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Model Details: Randomized, double-blind, and placebo-controlled study

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 12, 2026
• Study Start: January 13, 2025
• Primary Completion: October 11, 2025
• Study Completion: October 11, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

PL (1)