Cognitive Decline, Mild
Conditions
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.
Interventions
DIETARY_SUPPLEMENTHericium erinaceus
6 capsules per day, 3 times two after breakfast, lunch and dinner
DIETARY_SUPPLEMENTPlacebo
6 capsules per day, 3 times two after breakfast, lunch and dinner
Sponsors
University of Primorska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Randomized placebo controlled
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* age 55 - 75 years
Exclusion criteria
* neurodegenerative disease * organ transplantation * allergy to fungi * antibiotic consumption in the previous 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the microbial community composition in feces samples using next-generation sequencing | Change from Baseline Microbiota composition at 10 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cognitive function | Change from baseline Cognitive function at 10 weeks. | Test of perception speed patterns, Test of series |
| brain derived neurotrophic factor | Change from baseline Brain derived neurotrophic factor levels at 10 weeks. | serum level measured with ELISA assay |
| neuropeptide Y | Change from baseline Neuropeptide Y levels at 10 weeks. | serum level measured with ELISA assay |
Countries
Slovenia
Outcome results
None listed