Effects of Hericium Erinaceus on Microbiota and Cognition

Not Applicable

Completed

• Conditions: Cognitive Decline, Mild

• Registration Number: NCT04939961
• Lead Sponsor: University of Primorska

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.

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-17
• Study Start: 2021-06-18
• Study First Posted: 2021-06-25
• Primary Completion: 2021-09-20
• Study Completion: 2022-12-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• age 55 - 75 years

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Primorska, Faculty of Health Sciences; 🇸🇮 Izola, Slovenia