Effects of Hericium Erinaceus on Microbiota and Cognition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Hericium Erinaceus on Microbiota and Cognition in Older Adults

Conditions
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Cognitive Decline, Mild

Intervention / Treatment
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* Dietary Supplement: Hericium erinaceus
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 55 - 75 years Exclusion Criteria: neurodegenerative disease organ transplantation allergy to fungi antibiotic consumption in the previous 3 months

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized placebo controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hericium erinaceus<br>8 gram of mushroom Hericium erinaceus (containing 5 milligram of erinacines) per day | Dietary Supplement: Hericium erinaceus<br>* 6 capsules per day, 3 times two after breakfast, lunch and dinner<br>|
| Placebo Comparator: Placebo capsule<br>8 gram of allergen free corn starch per day | Dietary Supplement: Placebo<br>* 6 capsules per day, 3 times two after breakfast, lunch and dinner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |