Effects of Hericium Erinaceus on Microbiota and Cognition

NCT ID: NCT04939961

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-18
• Study Completion Date: 2022-12-20

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.

Conditions

Cognitive Decline, Mild

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Hericium erinaceus

8 gram of mushroom Hericium erinaceus (containing 5 milligram of erinacines) per day

Group Type: EXPERIMENTAL

Hericium erinaceus

Intervention Type: DIETARY_SUPPLEMENT

6 capsules per day, 3 times two after breakfast, lunch and dinner

Placebo capsule

8 gram of allergen free corn starch per day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

6 capsules per day, 3 times two after breakfast, lunch and dinner

Interventions

Hericium erinaceus

6 capsules per day, 3 times two after breakfast, lunch and dinner

Intervention Type: DIETARY_SUPPLEMENT

Placebo

6 capsules per day, 3 times two after breakfast, lunch and dinner

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• age 55 - 75 years

Exclusion Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Primorska

OTHER

Sponsor Role: lead

Responsible Party

Zala Jenko Praznikar

assoc. prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Primorska, Faculty of Health Sciences

Izola, , Slovenia

Countries

Slovenia

References

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.

Reference Type: BACKGROUND

PMID: 26244378 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31881712 (View on PubMed)

Other Identifiers

Hericium erinaceus

Identifier Type: -

Identifier Source: org_study_id