Clinical trial NCT04939961: Effects of Hericium Erinaceus on Microbiota and Cognition
Official title: Effects of Hericium Erinaceus on Microbiota and Cognition in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline, Mild
Lead sponsor: University of Primorska
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo controlled
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* age 55 - 75 years

Exclusion Criteria:

* neurodegenerative disease
* organ transplantation
* allergy to fungi
* antibiotic consumption in the previous 3 months

Primary outcomes:
measure: Assessment of the microbial community composition in feces samples using next-generation sequencing
timeFrame: Change from Baseline Microbiota composition at 10 weeks.
Secondary outcomes:
measure: cognitive function
timeFrame: Change from baseline Cognitive function at 10 weeks.
measure: brain derived neurotrophic factor
timeFrame: Change from baseline Brain derived neurotrophic factor levels at 10 weeks.
measure: neuropeptide Y
timeFrame: Change from baseline Neuropeptide Y levels at 10 weeks.
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
Study officials:
References:
citation: 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.
citation: 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.