Effects of Hericium Erinaceus on Microbiota and Cognition (HE)

• ClinicalTrials.gov Identifier: NCT04939961
• Recruitment Status: Completed
• First Posted: June 25, 2021
• Last Update Posted: March 1, 2023
• Sponsor: University of Primorska
• Information provided by (Responsible Party): Zala Jenko Praznikar, University of Primorska

Tracking Information

• First Submitted Date: June 10, 2021
• First Posted Date: June 25, 2021
• Last Update Posted Date: March 1, 2023
• Actual Study Start Date: June 18, 2021
• Actual Primary Completion Date: September 20, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 17, 2021)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 17, 2021)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Hericium Erinaceus on Microbiota and Cognition
• Official Title: Effects of Hericium Erinaceus on Microbiota and Cognition in Older Adults
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Cognitive Decline, Mild

Intervention

• Dietary Supplement: Hericium erinaceus
  6 capsules per day, 3 times two after breakfast, lunch and dinner
• Dietary Supplement: Placebo
  6 capsules per day, 3 times two after breakfast, lunch and dinner

Study Arms

• Experimental: Hericium erinaceus
  8 gram of mushroom Hericium erinaceus (containing 5 milligram of erinacines) per day
  Intervention: Dietary Supplement: Hericium erinaceus
• Placebo Comparator: Placebo capsule
  8 gram of allergen free corn starch per day
  Intervention: Dietary Supplement: Placebo

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 17, 2021): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 20, 2022
• Actual Primary Completion Date: September 20, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• age 55 - 75 years

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Slovenia

Administrative Information

• NCT Number: NCT04939961
• Other Study ID Numbers: Hericium erinaceus
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Zala Jenko Praznikar, University of Primorska
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Primorska
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Primorska
• Verification Date: February 2023