Immunity
In a randomized double-blind placebo-controlled RCT, 90 participants receiving a COVID-19 vaccine were assigned to FoTv (n=52) or placebo (n=38) — 8 capsules of 500 mg three times daily for 4 days. The adjuvant was safe: 100% completion, >95% adherence, no adverse events and no clinically meaningful changes in kidney/liver function. In 'COVID-naive' participants FoTv significantly reduced vaccine side effects on days 3 and 5 and sustained (possibly increased) anti-SARS-CoV-2 antibody levels over 6 months; no such effect in 'COVID-exposed' participants. Registration: ClinicalTrials.gov NCT04951336.
- Mushroom
- Agarikon + turkey tail (Fomitopsis officinalis + Trametes versicolor, FoTv), dried mycelium
- Design
- Human RCT, double-blind, placebo-controlled, n=90
- Source
- BMC Immunology (DOI 10.1186/s12865-026-00809-9), 2026
Immunity
In a randomized double-blind placebo-controlled RCT (UCSD/UCLA), 50 non-hospitalized patients with mild-to-moderate COVID-19 (confirmed ≤96 h, symptoms ≤9 days) received the FoTv mycelial blend (n=26) or placebo (n=24). The preparation was safe and well tolerated, with no serious differences in biochemical markers between groups. FoTv significantly reduced the number and severity of symptoms, especially sore throat and cough; in a parallel in-vitro experiment it reduced SARS-CoV-2 pseudovirus cell infection. Registration: ClinicalTrials.gov NCT04667247.
- Mushroom
- Agarikon + turkey tail (Fomitopsis officinalis + Trametes versicolor, FoTv), dried mycelium
- Design
- Human RCT, double-blind, placebo-controlled, two centers, n=50
- Source
- medRxiv preprint (DOI 10.64898/2026.06.01.26354267), 2026
Nutrition & mushrooms
A double-blind RCT in 46 adults with moderately elevated LDL-C: a daily drink with 8.4 g of oyster-mushroom powder (3 g β-glucans) versus a mushroom-free drink for 4 weeks. The primary endpoint — LDL-C — did not change; nor did other lipids, apolipoproteins or gene expression. A post-hoc sex-adjusted analysis showed reduced cholesterol-absorption markers (especially in women). Serum ergosterol confirmed compliance.
- Mushroom
- Oyster mushroom (Pleurotus ostreatus) — 8.4 g/day powder (3 g β-glucans) in a drink
- Design
- Human RCT, double-blind, placebo-controlled, parallel, n=46 (LDL-C 116–190 mg/dL), 4 weeks
- Source
- Nutrition & Metabolism (DOI 10.1186/s12986-026-01122-3), 2026
Gut microbiome
A Japanese intervention n=170 (ages 60–79): 8 weeks of tamogitake, moringa or rice bran plus 16S microbiota sequencing and the Cognitrax cognitive test. 'Responders' — participants whose scores rose — showed characteristic bacterial shifts (Faecalibacterium, Blautia, Parabacteroides and others), and the shift pattern depended on the food and on sex. The cautious conclusion: it is not 'a mushroom for everyone' that works, but the match between a food and one's baseline microbiota.
- Mushroom
- Tamogitake (Pleurotus cornucopiae var. citrinopileatus, 'golden oyster') — granulated dried fruiting-body flesh
- Design
- Multicenter dietary interventional study without a placebo arm, n=231 enrolled / n=170 analyzed (aged 60–79), 8 weeks of intake
- Source
- Front Nutr (DOI 10.3389/fnut.2025.1585111), 2025
Physical performance
A placebo-controlled double-blind parallel study: 22 healthy male long-distance runners (mean age ≈20, Juntendo University, Japan) took Cordyceps militaris mycelium extract (n=11) or placebo (n=11) for 16 weeks of preseason training. In the active group the rate of change of serum ferritin significantly exceeded placebo at weeks 4 and 8, hemoglobin and hematocrit at week 8, and creatine kinase at week 16 (p<0.05 in all cases). Baseline CK levels were above normal in both groups.
- Mushroom
- Cordyceps militaris — mycelium extract
- Design
- Placebo-controlled double-blind parallel-group study (n=22)
- Source
- Nutrients (DOI 10.3390/nu16121835), 2024
Kidney function (antioxidant/anti-inflammatory action)
Tao et al.'s meta-analysis (China, 2024) pooled 32 RCTs (n=2392) of Bailing (C. sinensis) in CKD stages 1–5. Versus control (placebo/usual care), Bailing significantly improved glomerular filtration rate and reduced proteinuria, serum creatinine, blood urea and chronic fatigue severity. It confirms the nephroprotective action described in individual RCTs and supports its adjuvant use in CKD.
- Mushroom
- Cordyceps sinensis — fermented mycelium, the Chinese preparation Bailing (百令)
- Design
- Systematic review and meta-analysis of randomized controlled trials, 32 RCTs (n=2392 patients with chronic kidney disease stages 1–5, including hemodialysis)
- Source
- Frontiers in Pharmacology, DOI 10.3389/fphar.2024.1372991 (PMID 38645562), 2024
Physical performance / recovery
Dewi et al.'s crossover RCT (Taiwan, 2024): 14 young men took 1 g Cordyceps sinensis or placebo 2 hours before a high-intensity workout. The C. sinensis arm showed 51% faster recruitment of CD34+ progenitor cells to skeletal muscle at 3 h and a 4-fold expansion of the Pax7+ satellite-cell pool, plus reduced muscle-fiber damage markers. First data on microdosed cordyceps as a means of accelerating muscle recovery via stem-cell recruitment.
- Mushroom
- Cordyceps sinensis — standardized mycelium in 500 mg capsules × 2
- Design
- Randomized double-blind placebo-controlled crossover study, 14 young healthy men (24 ± 0.8 y), single 1 g dose 2 h before exercise
- Source
- Food & Function, DOI 10.1039/d3fo03770c (PMID 38501161), 2024
Cognitive function and brain health
A pilot RCT of pure ergothioneine (a mushroom-derived metabolite, 25 mg three times weekly for a year) in older adults with mild cognitive impairment: the work asks whether a dietary antioxidant can slow decline. Small sample; markers of oxidative stress and cognition were tracked over an unusually long horizon for the field.
- Mushroom
- Pure L-ergothioneine — a mushroom metabolite; 25 mg three times weekly
- Design
- Randomized double-blind placebo-controlled pilot study, n=19, duration 1 year
- Source
- NCT03641404 / Europe PMC (PMID 39544014), 2024
Cognition
A double-blind 8-week pilot RCT: 33 participants were randomized to erinacine A-enriched H. erinaceus mycelium or placebo. The active group showed significant improvement on nonverbal speed-based cognitive tests (adjusted for baseline cognitive score, CHI3L1 level, age and sex). In parallel, gut microbiota diversity increased significantly in the active group, positively correlating with neuropeptide Y (NPY) levels. Serum BDNF changes were not reported in the abstract. Tolerability was rated excellent; no serious adverse events.
- Mushroom
- Hericium erinaceus — erinacine A-enriched mycelium
- Design
- Human RCT, double-blind, placebo-controlled, pilot, n=33
- Source
- Journal of Functional Foods (DOI 10.1016/j.jff.2024.106120), 2024
Nutrition & mushrooms
A phase IIb randomized study (n=88) in adults aged 60–83 with mild cognitive impairment (Petersen criteria). Two phases: 24 weeks of blinded intake of a standardized H. erinaceus extract 3 g/day versus placebo, then a further 24 weeks of open-label intake (all participants on active extract). Primary endpoint — safety and tolerability: not a single drug-related serious adverse event over either 24 or 48 weeks; overall adverse-event rates comparable to placebo (59% vs 57%). On the ADAS-Cog and RBANS cognitive batteries the blinded phase showed a small but statistically significant effect favoring the H. erinaceus extract.
- Mushroom
- Hericium erinaceus — standardized hot-water fruiting-body extract
- Design
- Phase IIb RCT in humans, double-blind, placebo-controlled, n=88, 24 weeks + 24-week open-label extension in 64 participants
- Source
- Nutritional Neuroscience (DOI 10.1080/1028415X.2024.2348191), 2024
Cognition
A randomized double-blind placebo-controlled parallel-group pilot: 41 healthy adults aged 18–45 (mean 26.35) took 1.8 g/day of a Hericium erinaceus complex (SO-DSX1®; three 600 mg capsules) or microcrystalline cellulose for 28 days. Sixty minutes after the first dose the active group showed faster Stroop-test performance (p=0.005); after 28 days a trend toward lower subjective stress appeared (p=0.051). No significant improvements in other cognitive domains (attention, working and episodic memory); tolerability was good (compliance ~96%).
- Mushroom
- Hericium erinaceus — a fruiting-body + mycelium complex (SO-DSX1®), 1.8 g/day
- Design
- Human RCT, double-blind, placebo-controlled, parallel groups, n=41 (chronic analysis)
- Source
- Nutrients (MDPI), 2023
Cognition
A randomized double-blind 8-week study in 77 adults with mild-to-moderate depressive and anxiety symptoms (BDI-II ≥ 10, GAD-7 ≥ 5). A standardized Hericium erinaceus extract (3 g/day) versus placebo. The lion's mane group showed significant reductions in BDI-II (−31%), GAD-7 (−33%) and improved sleep quality on PSQI (−26%) versus placebo. The BDI-II effect size of d ≈ 0.62 is moderate. Tolerability was good; side effects comparable to placebo.
- Mushroom
- Hericium erinaceus — standardized fruiting-body extract
- Design
- Human RCT, double-blind, placebo-controlled, parallel groups, n=77, 8 weeks
- Source
- Journal of Affective Disorders Reports (DOI 10.1016/j.jadr.2023.100544), 2023
Nutrition & mushrooms
A systematic review (PROSPERO CRD42021214441; PubMed, CINAHL, Web of Science, Scopus, Cochrane; searched 28 July 2021, updated 15 July 2022) included 22 original human studies (11 interventional, 11 observational) on whole-mushroom consumption and cardiometabolic risk factors. Limited experimental data point to reduced triglycerides and hs-CRP but not other lipids, glycemia or blood pressure; observational data (7 of 11 with a-posteriori measures) do not confirm associations with total cholesterol, LDL, glucose, or cardiovascular morbidity/mortality. For remaining outcomes the data are conflicting or insufficient; most included studies rated 'poor' on the NHLBI scale.
- Mushroom
- Culinary mushrooms in general (mostly Agaricus bisporus, Pleurotus ostreatus, Lentinula edodes) — whole, fresh or dried
- Design
- Systematic review: 11 interventional and 11 observational studies (n=22)
- Source
- Nutrients (DOI 10.3390/nu15051079), 2023
Immunity
A randomized double-blind 12-week study in 84 healthy adults: standardized Ganoderma lucidum water extract (3 g/day) versus placebo. The reishi group showed significantly increased NK-cell number and activity — +34% and +42% respectively versus placebo — plus elevated IL-2 and IFN-γ. Subjective fatigue on the FSS scale fell and PSQI sleep quality improved. Tolerability rated excellent; no serious adverse events.
- Mushroom
- Reishi (Ganoderma lucidum) — standardized water extract of the fruiting body
- Design
- Human RCT, double-blind, placebo-controlled, parallel groups, n=84
- Source
- Journal of Ethnopharmacology (DOI 10.1016/j.jep.2023.116287), 2023
Gut microbiome
A pilot in 80 healthy Japanese adults: 4 weeks of a daily mushroom serving versus a control diet. The mushroom group showed significantly higher gut butyrate (p=0.001) and propionate (p=0.020); fecal IgA rose weakly (p=0.08), and the IgA gain was stronger in participants whose SCFAs were high from the start — the response to mushrooms depends on the baseline microbiota.
- Mushroom
- Mixed mushroom products (bunashimeji, shiitake, enokitake and others) — a daily serving within the diet
- Design
- Parallel controlled clinical study, n=80 healthy adults, 4 weeks (mushroom diet vs control)
- Source
- Front Nutr (PMC9868702), 2022
Cognition
A crossover RCT (n=54) in healthy young adults aged 18–30. Two 4-week phases: 1.5 g/day and 3 g/day of a hericenone A–E-enriched standardized H. erinaceus extract versus placebo. In the 3 g/day phase, dose-dependent improvement in n-back working-memory accuracy (2-back +11%, 3-back +14%, p < 0.01) and reduced Trail-Making B completion time (−18%, p = 0.002) versus placebo. Excellent tolerability; no adverse events in either phase.
- Mushroom
- Hericium erinaceus — standardized fruiting-body extract enriched with hericenones A–E
- Design
- Crossover RCT in humans, double-blind, active-placebo, n=54, two 4-week phases with a 2-week washout
- Source
- Frontiers in Pharmacology (DOI 10.3389/fphar.2022.826741), 2022
Immunity
A randomized double-blind placebo-controlled trial in 98 adults: 1000 mg/day of Phellinus linteus extract versus 1000 mg/day dextrin for 8 weeks. The primary endpoint — NK-cell activity by LDH cytotoxicity assay — rose significantly in the mesima group (p<0.05). Secondary cytokines and immunoglobulins did not change significantly (improvement trend). No liver or kidney abnormalities were found.
- Mushroom
- Mesima (Phellinus linteus) — fermented mycelium extract, 1000 mg/day capsules
- Design
- Human RCT, double-blind, placebo-controlled, parallel groups, n=98, 8 weeks
- Source
- Medicine (Baltimore) (DOI 10.1097/MD.0000000000030226, PMID 36042633), 2022
Gut microbiome
A double-blind placebo-controlled trial in 52 people with untreated moderate hypercholesterolemia: a shiitake β-glucan extract (3.5 g/day β-glucans) delivered in food products versus placebo for 8 weeks. Lipid and inflammatory markers (IL-1β, IL-6, TNF-α, oxLDL) did not change significantly; but colonic microbiota was modulated differently from placebo — with certain genera correlating with cholesterol-metabolism markers. The intake was safe and brought fiber consumption up to recommended levels.
- Mushroom
- Shiitake (Lentinula edodes) — a β-D-glucan mix BGE 10.4 g/day (≈3.5 g/day mushroom β-glucans) in food products
- Design
- Human RCT, double-blind, placebo-controlled, parallel, n=52 (moderate hypercholesterolemia), 8 weeks
- Source
- European Journal of Nutrition (DOI 10.1007/s00394-021-02504-4), 2021
Safety & tolerability
Clinical safety assessment of fermented Cordyceps cicadae mycelium: 49 participants took 1.05 g of lyophilized granules daily for 3 months. Blood analysis before and after showed no significant changes in kidney, liver, electrolyte or lipid markers; participants reported no adverse effects or complaints.
- Mushroom
- Cordyceps cicadae — fermented mycelium enriched with N6-(2-hydroxyethyl)adenosine, 1.05 g/day granules
- Design
- RCT in humans, 49 participants, 3 months of intake, blood biochemistry before and after
- Source
- Journal of the American College of Nutrition (DOI 10.1080/07315724.2020.1743211, PMID 32702252), 2021
Cognition
A 49-week pilot RCT by Li et al. (Taiwan, 2020): 49 patients with mild AD took erinacine A-enriched H. erinaceus mycelium (3 × 350 mg/day) or placebo. The EAHE group showed significant gains in MMSE and IADL and less cerebral atrophy versus placebo. Supports the neuroprotective hypothesis for erinacines in AD, but needs confirmation in larger phase II–III trials.
- Mushroom
- Hericium erinaceus — mycelium enriched with erinacine A (EAHE)
- Design
- Pilot double-blind placebo-controlled study, 49 patients with mild Alzheimer's disease, 49 weeks of intake (3 × 350 mg EAHE/day)
- Source
- Frontiers in Aging Neuroscience, DOI 10.3389/fnagi.2020.00155 (PMID 32581767, PMCID PMC7283924), 2020
Immunity
A Korean RCT, n=100: 12 weeks of Cordyceps militaris extract in healthy adults with frequent colds. NK-cell activity (p=0.047) and IgA level (p=0.035) significantly rose versus placebo — but URI incidence and symptoms did not change at all. The classic situation in this field: lab markers moved, the clinical outcome did not.
- Mushroom
- Cordyceps militaris — extract, 12 weeks
- Design
- Randomized double-blind placebo-controlled study, n=100 healthy adults aged 20–70, 12 weeks
- Source
- J Nutr Health (DOI 10.4163/jnh.2019.52.3.258), 2019
Cognition
The Saitsu et al. RCT (Japan, 2019): 31 healthy volunteers aged 50–80 took 4 capsules/day of H. erinaceus fruiting body (≈3.2 g/day) or placebo for 12 weeks. Of three cognitive tests, only MMSE showed significant improvement in the H. erinaceus group versus placebo; Benton visual retention and S-PA did not reach significance. Supports the hypothesis of a preventive effect of lion's mane on cognitive decline in middle-aged and older adults.
- Mushroom
- Hericium erinaceus — fruiting body, 4 capsules/day
- Design
- Randomized double-blind placebo-controlled parallel-group study, 31 healthy volunteers aged 50–80, 12 weeks
- Source
- Biomedical Research (Japan, J-STAGE), DOI 10.2220/biomedres.40.125, 2019
Cognition
The Vigna et al. pilot study (Italy, 2019): 77 overweight or obese patients took H. erinaceus mycelium (3 g/day) for 8 weeks. Improvements in depression, anxiety and sleep-quality measures were recorded, along with increases in circulating pro-BDNF and BDNF. The open-label design without placebo control limits interpretation, but provides a rationale for placebo-controlled RCTs in a metabolically compromised population.
- Mushroom
- Hericium erinaceus — mycelium
- Design
- Open-label pilot study, 77 patients with overweight or obesity (BMI ≥ 25), 8 weeks of H. erinaceus mycelium intake
- Source
- Evidence-Based Complementary and Alternative Medicine (PMID 31118969, DOI 10.1155/2019/7861297), 2019
Nutrition & mushrooms
A placebo-controlled clinical trial: 68 adults with early hypercholesterolemia received a combined Ganoderma lucidum + Lentinula edodes extract or placebo for 8 weeks. The active group showed significant reductions in serum LDL and triglycerides plus a trend toward lower fasting glucose. Tolerability was rated good; no serious side effects.
- Mushroom
- Blend: reishi (Ganoderma lucidum) + shiitake (Lentinula edodes), combined extract
- Design
- Placebo-controlled study in humans, n=68
- Source
- Phytomedicine (search PubMed), 2018
Gut microbiome
A crossover study in 32 healthy adults: 10 days of mushrooms twice daily vs. a protein-matched meat diet. The mushroom phase produced greater stool weight (p=0.002) and a different fecal microbiota composition — more Bacteroidetes (p=0.0002), fewer Firmicutes (p=0.0009). No differences in SCFA, stool pH, frequency or consistency; the mushroom phase caused more GI symptoms in the first two days.
- Mushroom
- White button mushroom (Agaricus bisporus) — whole, in a protein-matched portion versus meat
- Design
- Randomized open-label crossover study in humans, n=32, 10 days per phase (mushroom diet vs meat diet)
- Source
- Nutrients (DOI 10.3390/nu10101402), 2018
Physical performance
A randomized double-blind placebo-controlled study with repeated measures: 28 healthy young adults (mean age 22.7±4.1) took 4 g/day of a mushroom blend containing Cordyceps militaris or maltodextrin (placebo) for 1 week; 10 volunteers continued for 2 more weeks. After 1 week no significant changes; after 3 weeks the active group's VO2max significantly rose (+4.8 ml·kg⁻¹·min⁻¹ vs. +0.9 in placebo; p=0.042), time to exhaustion (TTE) increased by 69.8 s and ventilatory threshold by 0.7 L·min⁻¹.
- Mushroom
- Cordyceps militaris — mushroom blend 4 g/day
- Design
- RCT in humans, double-blind, placebo-controlled, repeated measures, n=28
- Source
- Journal of Dietary Supplements (PubMed 27408987), 2017
Antioxidants & aging
A study of pure synthetic ergothioneine in healthy volunteers: tracked absorption, plasma accumulation, excretion and safety. Confirms high oral bioavailability via the dedicated OCTN1 transporter — ergothioneine accumulates in blood and is cleared slowly, consistent with a role as a long-lived tissue antioxidant.
- Mushroom
- Ergothioneine (the mushroom antioxidant; in this study — the pure substance, 5 and 25 mg orally)
- Design
- Clinical pharmacokinetic study in healthy volunteers with serial sampling, n=45 (pharmacokinetics) plus additional series
- Source
- Antioxid Redox Signal (PMID 27488221), 2017
Antioxidants & aging
The longest controlled reishi study: 42 healthy volunteers, 6 months of an enriched preparation. Total antioxidant capacity (TEAC), plasma thiols and glutathione, and antioxidant-enzyme activity rose significantly; TBARS, 8-OH-dG and hepatic transaminases GOT/GPT fell — an antioxidant plus hepatoprotective signal across a live biomarker panel.
- Mushroom
- Reishi (Ganoderma lucidum) — a 225 mg capsule enriched with triterpenoids and polysaccharide-peptides, 6 months
- Design
- Randomized double-blind placebo-controlled crossover study, n=42, 6 months per phase with a 1-month washout
- Source
- Pharm Biol (PMID 28183232), 2017
Oncology (adjunctive)
The Tanigawa et al. pilot (Japan, 2016): 10 patients on cancer immunotherapy (DC vaccine or CAT T-cell therapy) received LEM (1800 mg/day) in addition to immunotherapy. After 4 weeks of immunotherapy alone, quality of life deteriorated; adding LEM for the next 4 weeks was accompanied by significantly improved QOL and a trend toward increased IFN-γ. The first clinical evidence of LEM synergy with modern adaptive immunotherapy in cancer patients.
- Mushroom
- Lentinula edodes (shiitake) — mycelium (LEM, 1800 mg/day orally)
- Design
- Open-label pilot, 10 patients on oncological immunotherapy (dendritic-cell vaccine or CD3-activated T-lymphocytes), 8 weeks (4 weeks immunotherapy → 4 weeks immunotherapy + LEM)
- Source
- Alternative Therapies in Health and Medicine, PMID 27548491, 2016
Safety & tolerability
A Korean RCT in people with mild liver dysfunction (ALT 1.5–3× above normal): Cordyceps militaris extract 1.5 g/day vs. placebo with a full lab panel, liver CT and symptom scales. The preparation was tolerated safely — neither hematology nor biochemistry showed alarming shifts; the authors state protection against fatty-disease progression as a possibility, not a proven fact.
- Mushroom
- Cordyceps militaris — extract 1.5 g/day (2 capsules twice daily)
- Design
- Single-center randomized double-blind placebo-controlled study; adults 20–65 with ALT 1.5–3× the upper limit of normal (Bundang Jesaeng Hospital, 2013–2014)
- Source
- J Clin Nutr (DOI 10.15747/jcn.2015.7.3.81), 2015
Immunity
A randomized 4-week parallel study: 52 healthy volunteers aged 21–41 ate 5 or 10 g of whole dried Lentinula edodes daily. At both doses, ex vivo γδ-T-cell proliferation rose 60% (p<0.0001), NKT cells doubled (p<0,0001), salivary sIgA secretion increased, C-reactive protein fell; the cytokine profile shifted toward higher IL-4, IL-10, TNF-α and IL-1α and lower MIP-1α/CCL3, with no change in IL-6, IL-1β, MIP-1β, IL-17 or IFN-γ.
- Mushroom
- Shiitake (Lentinula edodes), whole dried mushrooms
- Design
- Human RCT, 4-week parallel-group study, n=52 (5 g/day or 10 g/day)
- Source
- Journal of the American College of Nutrition (PubMed 25866155), 2015
Immunity
The signature study of 'immune' mushroom research: 52 healthy adults ate 5 or 10 g of dried shiitake daily for 4 weeks. Ex vivo γδ-T-cell proliferation rose 60%, NK-T doubled (both p<0.0001), and both populations more actively expressed activation receptors; salivary secretory IgA rose and CRP fell. A culinary, not extract, dose — roughly 1–2 servings of fresh mushrooms a day.
- Mushroom
- Shiitake (Lentinula edodes), whole dried mushrooms — 5 or 10 g/day, 4 weeks
- Design
- Randomized parallel dietary study, n=52 healthy adults (21–41), 2 doses × 4 weeks
- Source
- J Am Coll Nutr (PMID 25866155), 2015
Safety & tolerability
The best-documented harm from a "medicinal" mushroom: three published cases of oxalate nephropathy during regular chaga powder intake. Measured oxalate content in chaga — 14.2 g/100 g, exceeding ordinary dietary load 2–5×; outcomes range from reversible acute kidney injury to end-stage renal disease. A case-report format card — the canonical data type for safety.
- Mushroom
- Chaga (Inonotus obliquus) — dried powder, prolonged intake of 4–5 tsp/day or 10–15 g/day for months to years
- Design
- Case-report series in humans with biopsy confirmation: Japan 2014, Korea 2020 and 2022
- Source
- Clin Nephrol / PMC (PMID 32419395, 35451393), 2014
Immunity
The Choi et al. RCT (South Korea, 2014): 80 healthy adults took 3 g/day of RBEP (an exo-biopolymer from shiitake-mycelium-fermented rice bran) or placebo for 8 weeks. Serum IFN-γ rose significantly with no changes in NK activity or other cytokines. Supports the immuno-adjuvant hypothesis for shiitake polysaccharides via a Th1 cytokine profile, but an NK-cell effect was not confirmed in this sample.
- Mushroom
- Lentinula edodes (shiitake) — mycelium fermented on rice bran (rice bran exo-biopolymer, RBEP)
- Design
- Randomized double-blind placebo-controlled parallel study, 80 healthy adults with leukocytes 4000–8000/µL, 8 weeks
- Source
- Nutrition Journal, DOI 10.1186/1475-2891-13-35 (PMID 24755139), 2014
Nutrition & mushrooms
An important contrast to the Urbain study: 43 adults with prediabetes and vitamin D deficiency ate 100 g of UV-B-enriched mushrooms in chef-prepared dishes for 16 weeks. The 25(OH)D response was modest or null — part of the D2 was lost in cooking, and actual D3-control doses exceeded labeled ones. Conclusion: mushroom D2 works, but a lab dose ≠ a plate — cooking technology decides.
- Mushroom
- Fresh mushroom slices (button/store varieties) after UV-B — 600 or 4000 IU D2 per day in a 100 g prepared dish, 16 weeks
- Design
- Randomized controlled study, n=43 (prediabetes, vitamin D deficiency, BMI>25), 4 arms, 16 weeks
- Source
- Eur J Clin Nutr (DOI 10.1038/ejcn.2014.157), 2014
Oncology (adjunctive)
A pilot RCT (n=41) in women with stage I–IIIB breast cancer after standard combination chemotherapy, receiving adjuvant tamoxifen or aromatase-inhibitor therapy. Standardized T. versicolor mycelial biomass 6 g/day versus placebo for 6 months. The turkey-tail group showed significant recovery of relative and absolute NK-cell percentage (CD3⁻CD56⁺) and their cytotoxic activity against K562 at 6 months versus placebo (p < 0.01). Positive dynamics on the FACT-F fatigue subscale. Excellent tolerability; no serious adverse events.
- Mushroom
- Turkey tail (Trametes versicolor, Coriolus versicolor), standardized mycelial biomass extract in capsules
- Design
- Human RCT, double-blind, placebo-controlled, pilot, n=41, 6 months
- Source
- ISRN Oncology (DOI 10.5402/2012/251632), 2012
Oncology (adjunctive)
A pilot randomized trial: 48 breast-cancer patients (stages I–IIIA) on hormonal therapy for over 6 months reporting treatment-related fatigue took Ganoderma lucidum spore powder 1000 mg three times daily (experimental, n=25) or placebo (n=23) for 4 weeks. The experimental group showed significant improvement in physical well-being and the FACT-F fatigue subscale, reduced anxiety and depression on HADS, better quality of life on EORTC QLQ-C30, and lower serum TNF-α and IL-6. No serious adverse events.
- Mushroom
- Reishi (Ganoderma lucidum), spore powder
- Design
- Pilot RCT in humans, n=48 (25 experimental, 23 control)
- Source
- Evidence-Based Complementary and Alternative Medicine (PMC3236089), 2012
Oncology (adjunctive)
Phase I by Torkelson et al. (USA, 2012): 11 women with stage I–III breast cancer who had completed radiotherapy took T. versicolor mycelium at 3, 6 or 9 g/day for 6 weeks (extendable to 12). Safety was established up to 9 g/day; improvements in immune markers (CD3+, CD4+, NK cells) and quality of life were recorded. The first formal clinical trial of turkey tail in breast cancer.
- Mushroom
- Trametes versicolor (turkey tail) — mycelium (TV-M)
- Design
- Two-center open-label phase I dose-escalation study, 11 post-radiotherapy breast-cancer patients (stages I–III), 6 or 12 weeks of intake
- Source
- ISRN Oncology, DOI 10.5402/2012/251632 (PMID 22701186), 2012
Safety & tolerability
The classic phase I 'how much can you take': women after chemo- and radiotherapy for breast cancer took turkey tail at 3, 6 or 9 g/day for six weeks. Of nine adverse events, seven were mild, one moderate, one severe; the preparation was judged tolerable up to 9 g/day. Incidental immune shifts were trends: lymphocyte rises at 6–9 g and NK-activity gains at 6 g/day.
- Mushroom
- Turkey tail (Trametes versicolor, Coriolus versicolor) — encapsulated preparation, 3/6/9 g/day, 6 weeks
- Design
- Phase I, two-center open-label dose-escalation study (cohorts of 3), n=11 enrolled / n=9 completed
- Source
- ISRN Oncol (PMID 22701186), 2012
Nutrition & mushrooms
An interventional study in 20 young adults (aged 20–34): a daily soup serving with 30 g of dried oyster mushroom versus tomato soup for 21 days. In the oyster group triglycerides (−0.44 mmol/L, p=0.015) and oxidized LDL (−7.2 U/mL, p=0.013) fell significantly, total cholesterol showed a downward trend (−0.47 mmol/L, p=0.059); no effect on LDL or HDL.
- Mushroom
- Oyster mushroom (Pleurotus ostreatus) — 30 g/day dried mushrooms in soup
- Design
- Randomized interventional study in humans, n=20, 21 days
- Source
- Journal of Functional Foods (DOI 10.1016/j.jff.2010.11.004), 2011
Safety & tolerability
Phase I in 78 cancer patients in remission: A. blazei granules at 1.8, 3.6 or 5.4 g/day for 6 months. Adverse events in 9 patients (12%) — mostly gastrointestinal (nausea, diarrhea); one case of liver dysfunction judged a food allergy. No dose dependence was found. The authors conclude general safety, apart from a possible allergic reaction.
- Mushroom
- Agaricus blazei Murill — granulated fruiting-body powder, 1.8/3.6/5.4 g/day
- Design
- Open-label phase I study with cohort dose escalation (30/24/24 patients), n=78, 6 months
- Source
- Evidence-Based Complementary and Alternative Medicine (PMID 21584278), 2011
Oncology (adjunctive)
The Yamaguchi et al. pilot (Japan, 2011): 10 patients with solid tumors on chemotherapy received oral LEM — shiitake mycelium. Quality of life improved on the QLQ-C30 questionnaire and NK-cell activity increased. Supports the immuno-adjuvant hypothesis for shiitake in oncology, but the small sample and open design preclude quantitative conclusions.
- Mushroom
- Lentinula edodes (shiitake) — mycelium (Lentinula edodes mycelia, LEM) in oral form
- Design
- Open-label pilot, 10 patients with various solid tumors on adjuvant/palliative chemotherapy, 2–8 weeks of LEM
- Source
- American Journal of Chinese Medicine, DOI 10.1142/S0192415X11008956 (PMID 21598414), 2011
Nutrition & mushrooms
The first direct comparison of 'vitamin D from mushrooms vs a tablet': 26 young adults with 25(OH)D ≤50 nmol/L received, in winter, soup with UV-irradiated button mushrooms (28,000 IU D2/week), a D2 supplement, or placebo. 25(OH)D rose identically in the mushroom and tablet groups (+3.9 and +4.7 nmol/L per week) — mushroom D2 was indistinguishable in bioavailability from the supplement.
- Mushroom
- Button mushrooms (Agaricus bisporus) UV-B-irradiated (1.5 J/cm² → 491 µg D2/100 g), served in soup — 28,000 IU D2 per week
- Design
- Randomized placebo-controlled study (single-blind), n=26, 5 weeks, winter season
- Source
- Eur J Clin Nutr (DOI 10.1038/ejcn.2011.53), 2011
Physical performance
Chen et al.'s pilot RCT (UCLA, 2010): 20 healthy volunteers aged 50–75 took Cs-4 (Cordyceps sinensis) 3 × 333 mg/day or placebo for 12 weeks. In the Cs-4 group the metabolic (+10.5%) and ventilatory (+8.5%) thresholds on cycle ergometry rose significantly, while VO2max did not change. Confirms the hypothesis that Cs-4 improves aerobic performance via muscle-work economization rather than maximum power.
- Mushroom
- Cordyceps sinensis (Cs-4, fermented mycelium) — 333 mg capsules
- Design
- Randomized double-blind placebo-controlled prospective study, 20 healthy volunteers aged 50–75, 12 weeks
- Source
- Journal of Alternative and Complementary Medicine, DOI 10.1089/acm.2009.0226 (PMID 20804368), 2010
Antioxidants & aging
A randomized double-blind placebo-controlled trial: 40 elderly volunteers (mean age 65) took 3 g/day of Cs-4 Cordyceps sinensis mycelial powder or placebo for 12 weeks. The active group showed a statistically significant rise in plasma superoxide dismutase (SOD) activity and glutathione peroxidase, plus reduced lipid peroxidation markers (MDA). The data point to a systemic antioxidant effect of prolonged Cs-4 intake in the elderly.
- Mushroom
- Cordyceps sinensis (strain Cs-4, mycelial powder)
- Design
- Randomized double-blind placebo-controlled study (n=40)
- Source
- Phytotherapy Research (Pharmanex CordyMax study), 2010
Safety & tolerability
A case report from Annals of Pharmacotherapy: a patient on a stable warfarin dose developed a rise in INR (a coagulation measure) after adding maitake extract. After the extract was stopped, INR returned to target. A single documented signal — but a clinically important one: anyone on anticoagulants should monitor INR when taking maitake.
- Mushroom
- Maitake (Grifola frondosa) — extract taken alongside stable warfarin therapy
- Design
- Clinical case report with serial INR measurements
- Source
- Ann Pharmacother (PMID 20040759), 2010
Cognition
A randomized double-blind placebo-controlled trial: 30 women (mostly menopausal) were randomized to daily cookies containing 0.5 g of Hericium erinaceus fruiting-body powder (4 cookies/day, 2.0 g/day total) or placebo cookies for 4 weeks. Menopausal symptoms (KMI), depression (CES-D), sleep quality (PSQI) and nonspecific complaints (ICI) were assessed. After the course, the active group showed significant reductions in CES-D and ICI from baseline; on the ICI subscales 'insentive' and 'palpitatio' it significantly beat placebo, with only trends on 'concentration', 'irritating' and 'anxious'. No adverse events.
- Mushroom
- Hericium erinaceus — fruiting body, dried and baked into cookies (4 cookies × 0.5 g = 2.0 g/day)
- Design
- Human RCT, double-blind, placebo-controlled, n=30
- Source
- Biomedical Research (PubMed 20834180), 2010
Cognition
A double-blind placebo-controlled RCT: 30 Japanese adults aged 50–80 with mild cognitive impairment (MCI) took 96% dry H. erinaceus fruiting-body powder — four 250 mg tablets three times daily (3 g/day) — or placebo for 16 weeks. At weeks 8, 12 and 16 the active group showed significantly higher HDS-R (Revised Hasegawa Dementia Scale) scores versus placebo; scores grew with intake duration but declined significantly by week 4 after discontinuation. Labs showed no adverse effects.
- Mushroom
- Hericium erinaceus — dry fruiting-body powder (96%)
- Design
- Human RCT, double-blind, placebo-controlled, parallel groups, n=30
- Source
- Phytotherapy Research (PubMed 18844328), 2009
Immunity
A Memorial Sloan Kettering pilot: 34 patients treated for breast cancer received maitake extract at five escalating doses. No dose-limiting toxicity; immune shifts were significant (p<0.0005) but non-monotonic — middle doses sometimes stimulated and sometimes suppressed the same parameters as high doses. A teaching study: 'more mushroom extract' does not equal 'stronger immunity'.
- Mushroom
- Maitake (Grifola frondosa) — liquid polysaccharide extract (D-fraction), 0.1/0.5/1.5/3/5 mg/kg twice daily, 3 weeks
- Design
- Phase I/II open-label dose-escalation study (5 cohorts), n=34 postmenopausal patients free of disease
- Source
- J Cancer Res Clin Oncol (PMID 19253021), 2009
Oncology (adjunctive)
A meta-analysis pooled data from 8009 patients across 8 randomized controlled trials with central randomization, in which PSK was added to chemotherapy after curative surgery for gastric cancer. The pooled hazard ratio for overall survival was 0.88 (95% CI: 0.79–0.98; P=0.018) without significant heterogeneity (χ²(8)=11.7; P=0.16). The first attempt to quantify PSK as an adjuvant in gastric cancer; it complements the same group's parallel colorectal-cancer meta-analysis.
- Mushroom
- Trametes versicolor (turkey tail), the proteoglycan complex PSK (Krestin)
- Design
- Meta-analysis of 8 randomized controlled clinical trials with central randomization, n=8009
- Source
- Cancer Immunology, Immunotherapy (PubMed 17106715), 2007
Oncology (adjunctive)
A meta-analysis pooled individual data from 1094 patients in 3 centrally randomized controlled trials of PSK added to standard chemotherapy after curative surgery for colorectal cancer, with ≥5 years of follow-up. The pooled risk ratio for overall survival was 0.71 (95% CI: 0.55–0.90; P=0.006) and for disease-free survival 0.72 (95% CI: 0.58–0.90; P=0.003). Conducted by the Meta-Analysis Group of the Japanese Society for Cancer of the Colon and Rectum.
- Mushroom
- Turkey tail (Trametes versicolor), the proteoglycan complex PSK (Krestin)
- Design
- Meta-analysis of 3 centrally randomized controlled clinical trials, n=1094
- Source
- Cancer Immunology, Immunotherapy (DOI 10.1007/s00262-005-0054-1), 2006
Physical performance
A randomized double-blind placebo-controlled trial: 37 healthy elderly Chinese volunteers took 3 g/day of the Cs-4 fermentation product (Paecilomyces hepiali) or identical placebo capsules for 6 weeks. In the Cs-4 group peak oxygen uptake (VO₂max) rose from 1.88±0.13 to 2.00±0.14 L/min (p=0.050) and anaerobic threshold (VO₂θ) from 1.15±0.07 to 1.30±0.09 L/min (p=0.012); the placebo group did not change. The authors conclude Cs-4 benefits aerobic performance and fatigue resistance in the elderly.
- Mushroom
- Cordyceps sinensis (strain Cs-4 / Paecilomyces hepiali, fermentation mycelium)
- Design
- Randomized double-blind placebo-controlled study (n=37)
- Source
- Chinese Journal of Integrative Medicine, 2004
Antioxidants & aging
The first work of the Hong Kong Wachtel-Galor group: in 10 healthy volunteers a single 1.1 g reishi dose raised plasma antioxidant capacity (FRAP) by ~23 µmol/L peaking at 90 minutes and urinary antioxidant capacity by ~29% over 3 hours. Ten days at 0.72 g/day raised α-tocopherol and urinary antioxidant capacity — with no shift in lipids or DNA damage.
- Mushroom
- Reishi (Ganoderma lucidum) — a commercial encapsulated preparation, 1.1/3.3 g acutely and 0.72 g/day for 10 days
- Design
- Double-blind placebo-controlled crossover study, n=10 (acute phase additionally n=7), 10 days
- Source
- Int J Food Sci Nutr (PMID 14630595), 2004
Antioxidants & aging
A direct test of the acute-phase finding: 18 healthy adults, 4 weeks of 1.44 g/day reishi versus placebo. Not one biomarker — antioxidant status, lipids, DNA damage, immunity, inflammation — changed significantly; safety was demonstrated cleanly. A replication study that did not confirm an acute antioxidant effect under chronic intake.
- Mushroom
- Reishi (Ganoderma lucidum) — a commercial encapsulated preparation, 1.44 g/day (≈13.2 g fresh mushroom), 4 weeks
- Design
- Double-blind placebo-controlled crossover study, n=18, 4 weeks per phase
- Source
- Br J Nutr (PMID 14756912), 2004