Effects of Hericium Erinaceus on Microbiota and Cognition

NCT04939961 | Completed

• 1 other identifier: Hericium erinaceus
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline, Mild

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from Baseline Microbiota composition at 10 weeks.

Secondary Outcomes (3)

• cognitive function

  Change from baseline Cognitive function at 10 weeks.

• brain derived neurotrophic factor

  Change from baseline Brain derived neurotrophic factor levels at 10 weeks.

• neuropeptide Y

  Change from baseline Neuropeptide Y levels at 10 weeks.

Study Arms (2)

Hericium erinaceus

EXPERIMENTAL

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

Dietary Supplement: Hericium erinaceus

Placebo capsule

PLACEBO COMPARATOR

8 gram of allergen free corn starch per day

Dietary Supplement: Placebo

Interventions

Hericium erinaceus DIETARY_SUPPLEMENT

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

Hericium erinaceus

Placebo DIETARY_SUPPLEMENT

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

Placebo capsule

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 55 - 75 years

You may not qualify if:

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

Sponsors & Collaborators

• University of Primorska: lead

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

Location

Related Publications (2)

• 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.

  PMID: 26244378 BACKGROUND

• 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.

  PMID: 31881712 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof.

Model Details: Randomized placebo controlled

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 25, 2021
• Study Start: June 18, 2021
• Primary Completion: September 20, 2021
• Study Completion: December 20, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)