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Effects of Hericium Erinaceus on Microbiota and Cognition (HE)

Primary Purpose

Cognitive Decline, Mild

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Hericium erinaceus
Placebo
Sponsored by
University of Primorska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline, Mild

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 55 - 75 years

Exclusion Criteria:

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

Sites / Locations

  • University of Primorska, Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hericium erinaceus

Placebo capsule

Arm Description

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

8 gram of allergen free corn starch per day

Outcomes

Primary Outcome Measures

Assessment of the microbial community composition in feces samples using next-generation sequencing
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

cognitive function
Test of perception speed patterns, Test of series
brain derived neurotrophic factor
serum level measured with ELISA assay
neuropeptide Y
serum level measured with ELISA assay

Full Information

First Posted
June 10, 2021
Last Updated
February 28, 2023
Sponsor
University of Primorska
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1. Study Identification

Unique Protocol Identification Number
NCT04939961
Brief Title
Effects of Hericium Erinaceus on Microbiota and Cognition
Acronym
HE
Official Title
Effects of Hericium Erinaceus on Microbiota and Cognition in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Primorska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Mild

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo controlled
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hericium erinaceus
Arm Type
Experimental
Arm Description
8 gram of mushroom Hericium erinaceus (containing 5 milligram of erinacines) per day
Arm Title
Placebo capsule
Arm Type
Placebo Comparator
Arm Description
8 gram of allergen free corn starch per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Hericium erinaceus
Intervention Description
6 capsules per day, 3 times two after breakfast, lunch and dinner
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
6 capsules per day, 3 times two after breakfast, lunch and dinner
Primary Outcome Measure Information:
Title
Assessment of the microbial community composition in feces samples using next-generation sequencing
Description
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.
Time Frame
Change from Baseline Microbiota composition at 10 weeks.
Secondary Outcome Measure Information:
Title
cognitive function
Description
Test of perception speed patterns, Test of series
Time Frame
Change from baseline Cognitive function at 10 weeks.
Title
brain derived neurotrophic factor
Description
serum level measured with ELISA assay
Time Frame
Change from baseline Brain derived neurotrophic factor levels at 10 weeks.
Title
neuropeptide Y
Description
serum level measured with ELISA assay
Time Frame
Change from baseline Neuropeptide Y levels at 10 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 55 - 75 years Exclusion Criteria: neurodegenerative disease organ transplantation allergy to fungi antibiotic consumption in the previous 3 months
Facility Information:
Facility Name
University of Primorska, Faculty of Health Sciences
City
Izola
ZIP/Postal Code
6310
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26244378
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.
Results Reference
background
PubMed Identifier
31881712
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.
Results Reference
background

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Effects of Hericium Erinaceus on Microbiota and Cognition

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