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Completed

NCT Number: NCT04939961

Effects of Hericium Erinaceus on Microbiota and Cognition

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.

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Key information

Conditions

Cognitive Decline, Mild Cognition Disorders Cognitive Dysfunction Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Neurocognitive Disorders

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 55 - 75 years

Exclusion criteria

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

Treatment and study plan

Hericium erinaceus

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Primorska

Other

Registry information

Official study title

Effects of Hericium Erinaceus on Microbiota and Cognition in Older Adults

Acronym: HE

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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