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Effects of Hericium Erinaceus on Microbiota and Cognition (HE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04939961
Recruitment Status : Completed
First Posted : June 25, 2021
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Zala Jenko Praznikar, University of Primorska

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognitive Decline, Mild Dietary Supplement: Hericium erinaceus Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized placebo controlled
Masking: Double (Participant, 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.
Primary Purpose: Prevention
Official Title: Effects of Hericium Erinaceus on Microbiota and Cognition in Older Adults
Actual Study Start Date : June 18, 2021
Actual Primary Completion Date : September 20, 2021
Actual Study Completion Date : December 20, 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. cognitive function [ Time Frame: Change from baseline Cognitive function at 10 weeks. ]
    Test of perception speed patterns, Test of series

  2. brain derived neurotrophic factor [ Time Frame: Change from baseline Brain derived neurotrophic factor levels at 10 weeks. ]
    serum level measured with ELISA assay

  3. neuropeptide Y [ Time Frame: Change from baseline Neuropeptide Y levels at 10 weeks. ]
    serum level measured with ELISA assay


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 55 - 75 years

Exclusion Criteria:

  • neurodegenerative disease
  • organ transplantation
  • allergy to fungi
  • antibiotic consumption in the previous 3 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939961


Locations
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Slovenia
University of Primorska, Faculty of Health Sciences
Izola, Slovenia, 6310
Sponsors and Collaborators
University of Primorska
More Information
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Publications:

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Responsible Party: Zala Jenko Praznikar, assoc. prof., University of Primorska
ClinicalTrials.gov Identifier: NCT04939961    
Other Study ID Numbers: Hericium erinaceus
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders