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The study evaluates the effects of Hericium erinaceus on microbiota, cognition, and other health parameters in older adults. All measurements will be performed at baseline and ten weeks after daily consumptions of either Hericium erinaceus or placebo.
Hericium erinaceus, a well-known edible mushroom, has numerous biological activities. Yamabushitake (Hericium erinaceus) is a mushroom that grows on both living and dead broadleaf trees. Yamabushitake is used as food in Japan and China. Hericenones and erinacines stimulate nerve growth factor synthesis, and therefore it is expected that H. erinaceus have some effects on brain functions and autonomic nervous system. Hericium was tested in several applications, such as dementia, Alzheimer's disease, Parkinson's disease, multiple sclerosis, neuropathy and neurasthenia. The ancient Chinese knew about these possibilities and used it to support mental functions and memory, concentration. It is also very good for various digestive problems, such as gastritis, stomach ulcers, heartburn, reflux and improvement of digestion.
Therefore, the aim of our study is to evaluate the effects of Hericium erinaceus on microbiota, cognition and related parameters in elderly. The stool samples will be taken at baseline and after ten weeks of daily consumption of Hericium erinaceus or placebo. In addition, cognitive tests, anthropometric measurements, and blood analysis (lipid profile, glucose levels and neurotrophic factors) will be measured at the same time points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hericium erinaceus | Experimental | 8 gram of mushroom Hericium erinaceus (containing 5 milligram of erinacines) per day |
|
| Placebo capsule | Placebo Comparator | 8 gram of allergen free corn starch per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hericium erinaceus | Dietary Supplement | 6 capsules per day, 3 times two after breakfast, lunch and dinner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the microbial community composition in feces samples using next-generation sequencing | For the assessment of the microbial community composition, DNA will be extracted from the frozen faecal samples (1-2 gram) with the commercial DNA Stool Mini Kit. A comparison of microbiota among treatments will be done with a meta-barcoding approach using ribosomal RNA markers with modified primers. | Change from Baseline Microbiota composition at 10 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| cognitive function | Test of perception speed patterns, Test of series | Change from baseline Cognitive function at 10 weeks. |
| brain derived neurotrophic factor | serum level measured with ELISA assay |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Primorska, Faculty of Health Sciences | Izola | 6310 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26244378 | Background | Friedman M. Chemistry, Nutrition, and Health-Promoting Properties of Hericium erinaceus (Lion's Mane) Mushroom Fruiting Bodies and Mycelia and Their Bioactive Compounds. J Agric Food Chem. 2015 Aug 19;63(32):7108-23. doi: 10.1021/acs.jafc.5b02914. Epub 2015 Aug 5. | |
| 31881712 | Background | Chong PS, Fung ML, Wong KH, Lim LW. Therapeutic Potential of Hericium erinaceus for Depressive Disorder. Int J Mol Sci. 2019 Dec 25;21(1):163. doi: 10.3390/ijms21010163. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
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Randomized placebo controlled
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Placebo and experimental capsules (A and B) were prepared by collaborator-investigator (MycoMedica). Both experimental and placebo capsules appear similar to each other in terms of colour, flavour, size, and shape to make sure that they cannot be distinguished. Information about capsules will be provided to participants and investigators at the end of the trial.
| Placebo | Dietary Supplement | 6 capsules per day, 3 times two after breakfast, lunch and dinner |
|
| Change from baseline Brain derived neurotrophic factor levels at 10 weeks. |
| neuropeptide Y | serum level measured with ELISA assay | Change from baseline Neuropeptide Y levels at 10 weeks. |
| D008223 |
| Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |