NCT07405632

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: University of Social Sciences and Humanities, Warsaw · Academic / Other
• Sex: Female
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Attention
• Memory
• Cognitive Function and Well-Being

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Hericium erinaceus Supplementation	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.\*
DIETARY_SUPPLEMENT	Placebo	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.\*

Timeline

• Start date: 2025-01-13
• Primary completion: 2025-10-11
• Completion: 2025-10-11
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: Poland