Cognitive Decline, MildHENCT04939961
Effects of Hericium Erinaceus on Microbiota and Cognition
A study testing Hericium erinaceus in people with Cognitive Decline, Mild, run by University of Primorska at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Mild
- What is being tested?
- Hericium erinaceus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 18 Jun 2021to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 55 - 75 years
Who cannot join
- neurodegenerative disease
- organ transplantation
- allergy to fungi
- antibiotic consumption in the previous 3 months
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska, Faculty of Health Sciences
Izola, 6310
About this study
Official title: Effects of Hericium Erinaceus on Microbiota and Cognition in Older Adults
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.
Read the 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.
- Conditions
- Cognitive Decline, Mild
- Being tested
- Hericium erinaceus, Placebo
- Medical subject headings
- Cognitive Dysfunction, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hericium erinaceusDietary supplement
6 capsules per day, 3 times two after breakfast, lunch and dinner
PlaceboDietary supplement
6 capsules per day, 3 times two after breakfast, lunch and dinner
| Study group | Role | What they receive |
|---|---|---|
| Hericium erinaceus | Experimental | 8 gram of mushroom Hericium erinaceus (containing 5 milligram of erinacines) per day Receives: Dietary Supplement: Hericium erinaceus |
| Placebo capsule | Placebo comparator | 8 gram of allergen free corn starch per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Microbiota composition at 10 weeks.
Secondary outcomes (3)
cognitive function
Test of perception speed patterns, Test of series
Measured: Change from baseline Cognitive function at 10 weeks.
brain derived neurotrophic factor
serum level measured with ELISA assay
Measured: Change from baseline Brain derived neurotrophic factor levels at 10 weeks.
neuropeptide Y
serum level measured with ELISA assay
Measured: Change from baseline Neuropeptide Y levels at 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start18 Jun 2021
- Primary completion20 Sep 2021
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive Decline, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zala Jenko Praznikar, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939961
- Sponsor's protocol ID
- Hericium erinaceus
- Acronym
- HE
- Status last verified
- Feb 2023
- First submitted
- 10 Jun 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26244378Chong 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.
PubMed 31881712
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hericium Erinaceus on Microbiota and Cognition in Older Adults
- ClinicalTrials.gov ID
- NCT04939961
- Acronym / sponsor ID
- HE / Hericium erinaceus
- Conditions
- Cognitive Decline, Mild
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Hericium erinaceus | Experimental | Dietary Supplement: Hericium erinaceus8 gram of mushroom Hericium erinaceus (containing 5 milligram of erinacines) per day |
| Placebo capsule | Placebo comparator | Dietary Supplement: Placebo8 gram of allergen free corn starch per day |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 55 - 75 years
Key exclusion criteria (4 listed)
- neurodegenerative disease
- organ transplantation
- allergy to fungi
- antibiotic consumption in the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hericium erinaceus6 capsules per day, 3 times two after breakfast, lunch and dinner | Dietary supplement | Hericium erinaceus |
| Placebo6 capsules per day, 3 times two after breakfast, lunch and dinner | Dietary supplement | Placebo capsule |
Primary outcome
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.
3 secondary outcomes
cognitive function
Time frame: Change from baseline Cognitive function at 10 weeks.
brain derived neurotrophic factor
Time frame: Change from baseline Brain derived neurotrophic factor levels at 10 weeks.
neuropeptide Y
Time frame: Change from baseline Neuropeptide Y levels at 10 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 26244378Friedman 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.
- Background: PubMed 31881712Chong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hericium erinaceus in people with Cognitive Decline, Mild, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the microbial community composition in feces samples using next-generation sequencing (time frame: Change from Baseline Microbiota composition at 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04939961, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.