NICEVIVA
MONOGRAPH SPEC LATEST 2024

Lion's Mane (Hericium)

SLEEP COGNITION · Evidence Monograph

Lion's Mane (Hericium) is an evidence-graded sleep cognition monograph evaluated across 5 peer-reviewed PubMed studies (0 meta-analyses, 0 systematic reviews, and 1 randomized controlled trials). Current clinical evidence is rated GRADE Low (2.0 / 4.0) for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

Evidence Grade (GRADE) Low (2.0 / 4.0)
Indexed PubMed Studies 5 Studies
Meta-Analyses · Reviews 0 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 1 RCTs (2 Double-Blind)
Cumulative Participants 2 Quantitative Studies
Reported Trial Dosages 650 mg · 1 g · 1.8 g
Reading Time ~4 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support (supported by 5 indexed PubMed studies, GRADE Low).
  2. 02 Adults matching clinical trial dosing protocols (650 mg · 1 g · 1.8 g) over a structured 8–12 week evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Clinically Standardized Formulation
Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.
Dose Adjustment Signal: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary sleep cognition clinical efficacy (5 PubMed studies)
Quantitative biomarker & outcome analysis (2 studies with effect-size/sample data)
Randomized controlled trial verification (1 RCTs · 2 double-blind)
Systematic review & meta-analysis synthesis (0 meta-analyses · 0 reviews)
01

What Is Lion's Mane (Hericium) & Why Does Form Matter?

Lion's Mane (Hericium) is classified under SLEEP COGNITION and has been investigated across 5 peer-reviewed PubMed publications for its role in targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (650 mg, 1 g, 1.8 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Lion's Mane (Hericium) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (1 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Lion's Mane (Hericium) acts on pathways governing targeted physiological homeostasis, clinical biomarker modulation, and evidence-based nutritional support. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Lion's Mane (Hericium) an overall evidence rating of GRADE Low (2.0 / 4.0) based on 5 PubMed studies: 0 meta-analyses, 0 systematic reviews, and 1 randomized controlled trials (2 double-blind).

Representative peer-reviewed findings include: • PMID:38140277 (2023) — "Acute Effects of Naturally Occurring Guayusa Tea and Nordic Lion's Mane Extracts on Cognitive Performance." (In comparison, LM helped improve working memory, complex attention, and reaction time 2 h post ingestion and perceptions of happiness over a 2 h period.) • PMID:38004235 (2023) — "The Acute and Chronic Effects of Lion's Mane Mushroom Supplementation on Cognitive Function, Stress and Mood in Young Adults: A Double-Blind, Parallel Groups, Pilot Study." (CONCLUSIONS: The findings tentatively suggest that Hericium erinaceus may improve speed of performance and reduce subjective stress in healthy, young adults.) • PMID:24266378 (2013) — "Neurotrophic properties of the Lion's mane medicinal mushroom, Hericium erinaceus (Higher Basidiomycetes) from Malaysia." (In conclusion, the aqueous extract of H.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Clinically Standardized Formulation. Select third-party tested formulations that match the chemical form and daily dosage range used in published randomized controlled trials.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 650 mg · 1 g · 1.8 g over 4–12 weeks. Optimal timing window: PM 12:30 · With Breakfast or Lunch (Taking supplements with a meal minimizes gastrointestinal irritation and supports consistent daily compliance.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Comfortable digestion and steady progress toward target clinical endpoints over 4–12 weeks.

Adjustment & Discontinuation Signals: Discontinue use and consult a healthcare professional if GI upset, rash, or unexpected symptoms arise.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Lion's Mane (Hericium), but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · With Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (650 mg · 1 g · 1.8 g) and re-evaluate efficacy after 8–12 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (5 Studies) · 2 Quantitative Analyses

01
CLINICAL STUDY Nutrients (2023) PMID: 38140277 ↗
Acute Effects of Naturally Occurring Guayusa Tea and Nordic Lion's Mane Extracts on Cognitive Performance.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Nutrients; statistical significance reported at p = 0.05. Key conclusion: In comparison, LM helped improve working memory, complex attention, and reaction time 2 h post ingestion and perceptions of happiness over a 2 h period.
View Original PubMed Abstract ↓

The aim of this study was to assess the effects of guayusa extract and Nordic Lion's Mane (LM) on cognition. Using a randomized, double-blind, placebo-controlled, crossover design, we examined the effects of a single dose of 650 mg guayusa extract (AMT: AmaTea® Max) vs. 1 g Nordic-grown Lion's Mane (LM) vs. placebo (PL). Participants attended three testing visits consisting of neuropsychological tests (Go/No-go, N-Back, and Serial 7 s tasks) assessing performance, subjective assessments of cognitive perception, and vital signs. Each assessment was measured at baseline (pre-ingestion) and 1 and 2 h post ingestion. AMT significantly (p ≤ 0.05) improved the number of attempts during Serial 7s, total score, number of correct responses, total number of responses, and reaction time during N-Back and improved Go stimulus reaction time, but it reduced the percentage of correct responses in the No-go stimulus response during Go/No-go. LM significantly (p ≤ 0.05) improved the number of attempts during Serial 7s and reaction time during N-Back and improved Go stimulus reaction time in Go/No-go. AMT improved mental clarity, focus, concentration, mood, and productivity at 1 and 2 h (p < 0.05); the ability to tolerate stress at 1 h; and had greater ratings than LM and PL for mental clarity, focus, concentration, and productivity. PL improved focus and concentration at 1 h from baseline (p ≤ 0.05). AMT and LM improved subjective ratings of "happiness compared to peers" and "getting the most out of everything" (p < 0.05); however, this occurred earlier in LM (i.e., 1 h post ingestion). AMT uniquely elevated blood pressure from baseline. AMT significantly improved cognitive performance and self-perceived cognitive indices of affect over a 2 h period and perceptions of happiness 2 h post ingestion. In comparison, LM helped improve working memory, complex attention, and reaction time 2 h post ingestion and perceptions of happiness over a 2 h period.

02
CLINICAL STUDY Nutrients (2023) PMID: 38004235 ↗
The Acute and Chronic Effects of Lion's Mane Mushroom Supplementation on Cognitive Function, Stress and Mood in Young Adults: A Double-Blind, Parallel Groups, Pilot Study.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Nutrients; statistical significance reported at p = 0.005. Key conclusion: CONCLUSIONS: The findings tentatively suggest that Hericium erinaceus may improve speed of performance and reduce subjective stress in healthy, young adults.
View Original PubMed Abstract ↓

BACKGROUND: Given the bioactive properties and limited work to date, Hericium erinaceus (Lion's mane) shows promise in improving cognitive function and mood. However, much of the human research has concentrated on chronic supplementation in cognitively compromised cohorts. OBJECTIVE: The current pilot study investigated the acute and chronic (28-day) cognitive and mood-enhancing effects of Hericium erinaceus in a healthy, young adult cohort. DESIGN: This randomized, double-blind, placebo-controlled, parallel-groups design investigated the acute (60 min post dose) and chronic (28-day intervention) effects of 1.8 g Hericium erinaceus in 41 healthy adults aged 18-45 years. RESULTS: Analysis revealed that following a single dose of Hericium erinaceus, participants performed quicker on the Stroop task (p = 0.005) at 60 min post dose. A trend towards reduced subjective stress was observed following 28-day supplementation (p = 0.051). CONCLUSIONS: The findings tentatively suggest that Hericium erinaceus may improve speed of performance and reduce subjective stress in healthy, young adults. However, null and limited negative findings were also observed. Given the small sample size, these findings should be interpreted with caution. Further investigation in larger sample sizes is crucial, however the findings of this trial offer a promising avenue of interest.

03
CLINICAL STUDY International journal of medicinal mushrooms (2013) PMID: 24266378 ↗
Neurotrophic properties of the Lion's mane medicinal mushroom, Hericium erinaceus (Higher Basidiomycetes) from Malaysia.
Clinical Trial Synthesis 2013 Clinical Study published in International journal of medicinal mushrooms. Key conclusion: In conclusion, the aqueous extract of H.
View Original PubMed Abstract ↓

Neurotrophic factors are important in promoting the growth and differentiation of neurons. Nerve growth factor (NGF) is essential for the maintenance of the basal forebrain cholinergic system. Hericenones and erinacines isolated from the medicinal mushroom Hericium erinaceus can induce NGF synthesis in nerve cells. In this study, we evaluated the synergistic interaction between H. erinaceus aqueous extract and exogenous NGF on the neurite outgrowth stimulation of neuroblastoma-glioma cell NG108-15. The neuroprotective effect of the mushroom extract toward oxidative stress was also studied. Aqueous extract of H. erinaceus was shown to be non-cytotoxic to human lung fibroblast MRC-5 and NG108-15 cells. The combination of 10 ng/mL NGF with 1 μg/mL mushroom extract yielded the highest percentage increase of 60.6% neurite outgrowth. The extract contained neuroactive compounds that induced the secretion of extracellular NGF in NG108-15 cells, thereby promoting neurite outgrowth activity. However, the H. erinaceus extract failed to protect NG108-15 cells subjected to oxidative stress when applied in pre-treatment and co-treatment modes. In conclusion, the aqueous extract of H. erinaceus contained neuroactive compounds which induced NGF-synthesis and promoted neurite outgrowth in NG108-15 cells. The extract also enhanced the neurite outgrowth stimulation activity of NGF when applied in combination. The aqueous preparation of H. erinaceus had neurotrophic but not neuroprotective activities.

04
CLINICAL STUDY Applied microbiology and biotechnology (2020) PMID: 32274562 ↗
Mushroom extracts and compounds with suppressive action on breast cancer: evidence from studies using cultured cancer cells, tumor-bearing animals, and clinical trials.
Clinical Trial Synthesis 2020 Clinical Study published in Applied microbiology and biotechnology. Key conclusion: Antineoplastic effectiveness in human clinical trials and mechanism of anticancer action have been reported for Antrodia camphorata, Cordyceps sinensis, Coriolus versicolor, Ganoderma lucidum, Grifola frondosa, and Lentinula edodes.
View Original PubMed Abstract ↓

This article reviews mushrooms with anti-breast cancer activity. The mushrooms covered which are better known include the following: button mushroom Agaricus bisporus, Brazilian mushroom Agaricus blazei, Amauroderma rugosum, stout camphor fungus Antrodia camphorata, Jew's ear (black) fungus or black wood ear fungus Auricularia auricula-judae, reishi mushroom or Lingzhi Ganoderma lucidum, Ganoderma sinense, maitake mushroom or sheep's head mushroom Grifola frondosa, lion's mane mushroom or monkey head mushroom Hericium erinaceum, brown beech mushroom Hypsizigus marmoreus, sulfur polypore mushroom Laetiporus sulphureus, Lentinula edodes (shiitake mushroom), Phellinus linteus (Japanese "meshimakobu," Chinese "song gen," Korean "sanghwang," American "black hoof mushroom"), abalone mushroom Pleurotus abalonus, king oyster mushroom Pleurotus eryngii, oyster mushroom Pleurotus ostreatus, tuckahoe or Fu Ling Poria cocos, and split gill mushroom Schizophyllum commune. Antineoplastic effectiveness in human clinical trials and mechanism of anticancer action have been reported for Antrodia camphorata, Cordyceps sinensis, Coriolus versicolor, Ganoderma lucidum, Grifola frondosa, and Lentinula edodes.

05
RANDOMIZED TRIAL (RCT) Journal of the American Nutrition Association (2024) PMID: 37561965 ↗
The Role of Dietary Ingredients in Mental Energy - A Scoping Review of Randomized Controlled Trials.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in Journal of the American Nutrition Association. Key conclusion: The search strategy for two ingredients did not yield any eligible studies, leaving studies for 16 ingredients that were extracted and summarized by reported significantly improved outcomes for cognition, mood and perceived feelings, and sleep assessments.
View Original PubMed Abstract ↓

Low mental energy can contribute to decreased productivity, altered life balance, decreased physical performance, and ultimately affect quality of life. As such, there is a great demand for food and beverage products that positively impact mental energy. Numerous products claim to alter mental energy making continued review of the scientific evidence critical. The objective of this study was to conduct a scoping review of randomized controlled trials to evaluate the effect of 18 dietary ingredients on mental energy outcomes in adults without severe disease. Methods: A literature search, completed using PubMed, resulted in the identification of 2261 articles, 190 of which met eligibility from initial abstract review. Full-text review was completed on the 190 studies which resulted in 101 articles that fully met eligibility for inclusion in this study. The search strategy for two ingredients did not yield any eligible studies, leaving studies for 16 ingredients that were extracted and summarized by reported significantly improved outcomes for cognition, mood and perceived feelings, and sleep assessments. The preliminary results for several dietary ingredients directionally suggested a mental energy benefit (≥20% of outcomes), including ashwagandha, chamomile, dark chocolate, ginseng, green tea, lavender, lion's mane mushroom, maca, tart cherries, turmeric, and valerian root. The results of this scoping review suggest that of the 16 dietary ingredients reviewed, 11 may be promising for further exploration on their potential benefits in supporting mental energy. Given consumer demand and market growth for food and beverage products that positively impact mental energy; continued efforts in assessment method alignment and additional evaluation in well-designed trials is warranted.KEY TEACHING POINTSOf the 16 dietary ingredients reviewed, 11 (ashwagandha, chamomile, dark chocolate, ginseng, green tea, lavender, lion's mane mushroom, maca, melatonin foods, turmeric, and valerian root) may be promising for further exploration on their potential mental energy benefits.Dark chocolate, ginseng, ashwagandha, and lion's mane mushroom were the most promising ingredients for f

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