Effects of Hericium Erinaceus on Microbiota and Cognition (HE)

February 28, 2023 updated by: Zala Jenko Praznikar, University of Primorska

Effects of Hericium Erinaceus on Microbiota and Cognition in Older Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Izola, Slovenia, 6310
        • University of Primorska, Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 55 - 75 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the microbial community composition in feces samples using next-generation sequencing
Time Frame: 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.
Change from Baseline Microbiota composition at 10 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive function
Time Frame: Change from baseline Cognitive function at 10 weeks.
Test of perception speed patterns, Test of series
Change from baseline Cognitive function at 10 weeks.
brain derived neurotrophic factor
Time Frame: Change from baseline Brain derived neurotrophic factor levels at 10 weeks.
serum level measured with ELISA assay
Change from baseline Brain derived neurotrophic factor levels at 10 weeks.
neuropeptide Y
Time Frame: Change from baseline Neuropeptide Y levels at 10 weeks.
serum level measured with ELISA assay
Change from baseline Neuropeptide Y levels at 10 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Primorska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2021

Primary Completion (Actual)

September 20, 2021

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hericium erinaceus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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