DementiaNCT07775833
Study Protocol: The Efficacy of Mushroom to Reduce Cognitive Decline in At-Risk Middle-aged Adults and Young-olds Living in the Community
A study testing Golden oyster mushroom powder in people with Dementia and Cognitive Assessment, run by National University of Singapore at 1 site in Singapore.
Trial summary
The investigator's objective is to explore the definitive evidence of mushroom on cognitive functions among at-risk middle-aged and young-olds. The investigator carefully designed a randomized controlled trial (RCT) to assess the role of mushrooms in promoting cognitive functioning among around 600 middle-aged adults… Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Cognitive Assessment
- What is being tested?
- Golden oyster mushroom powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1) Community-living adult aged 45 years to 80 years, AND
- (2) Family history of Alzheimer's disease or having subjective cognitive (SCD) defined as "self-reported memory problems that have been getting worse over the past year.", AND
- (3) Consume mushrooms no more than once a week, AND
- (4) No dementia: CDR global score equal to zero.
Who cannot join
- (1) Any diagnosis of neurological diseases (e.g., epilepsy, stroke) made by a clinician, OR
- (2) Any diagnosis of psychiatric illnesses (e.g., depressive disorders) made by a clinician, OR
- (3) Significant sensory or motor impairments, OR
- (4) Known allergy to mushrooms or a history of serious food allergies, OR
- (5) Participants with a history of gout, OR
- (6) Diagnosed with hyperuricemia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Tahir Foundation Building, MD1, Level 12 (12 Science Drive 2)
Singapore, 117549
Kai Xuan Lim, +65 90553343, kaixuan@nus.edu.sg
About this study
The investigator's objective is to explore the definitive evidence of mushroom on cognitive functions among at-risk middle-aged and young-olds.
The investigator carefully designed a randomized controlled trial (RCT) to assess the role of mushrooms in promoting cognitive functioning among around 600 middle-aged adults and young-olds.
Participants were selected based on specific inclusion criteria, such as being community-living adults aged 45-80 years with a family history of dementia or subjective cognitive decline, while consuming mushrooms no more than once a week and having no dementia, along with the exclusion of individuals with neurological or psychiatric disorders and significant sensory or motor impairments. Participants in the intervention group will consume Pleurotus citrinopileatus mushroom powder daily for 24months, with compliance
- Conditions
- Dementia, Cognitive Assessment
- Being tested
- Golden oyster mushroom powder
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golden oyster mushroom powderDietary supplement
Participants in the intervention group will consume Pleurotus citrinopileatus mushroom powder daily for 24months, with compliance monitored using electronic diary apps. The powder contains 7.0 mg/g of ergothioneine (dry weight).
| Study group | Role | What they receive |
|---|---|---|
| mushroom powder intervention arm | Experimental | Not described Receives: Dietary Supplement: Golden oyster mushroom powder |
| Placebo arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
Total scores change
Measured: 24 months
Secondary outcomes (7)
plasma ergothioneine
Measured: 24 months
Rey Auditory Verbal Learning Test
Measured: 12, and 24 months
inflammatory markers
hs-CRP, TNFα, IL-1, IL-6, and etc
Measured: 24 months
NfL
Measured: 24 months
Epigenetic age
Measured: 24 months
Symbol Digit Modality test
Measured: 12, and 24 months
Clinical Dementia Rating
Measured: 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Lei, National University of Singapore
- Investigators
- Lei FEng, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775833
- Sponsor's protocol ID
- NUS-IRB-2025-118
- Status last verified
- Apr 2026
- First submitted
- 21 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol: The Efficacy of Mushroom to Reduce Cognitive Decline in At-Risk Middle-aged Adults and Young-olds Living in the Community
- ClinicalTrials.gov ID
- NCT07775833
- Acronym / sponsor ID
- NUS-IRB-2025-118
- Conditions
- Dementia, Cognitive Assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Aug 2026 (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 investigator's objective is to explore the definitive evidence of mushroom on cognitive functions among at-risk middle-aged and young-olds.
The investigator carefully designed a randomized controlled trial (RCT) to assess the role of mushrooms in promoting cognitive functioning among around 600 middle-aged adults and young-olds.
Participants were selected based on specific inclusion criteria, such as being community-living adults aged 45-80 years with a family history of dementia or subjective cognitive decline, while consuming mushrooms no more than once a week and having no dementia, along with the exclusion of individuals with neurological or psychiatric disorders and significant sensory or motor impairments. Participants in the intervention group will consume Pleurotus citrinopileatus mushroom powder daily for 24months, with compliance
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mushroom powder intervention arm | Experimental | Dietary Supplement: Golden oyster mushroom powder |
| Placebo arm | No intervention | – |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) Community-living adult aged 45 years to 80 years, AND
- (2) Family history of Alzheimer's disease or having subjective cognitive (SCD) defined as "self-reported memory problems that have been getting worse over the past year.", AND
- (3) Consume mushrooms no more than once a week, AND
- (4) No dementia: CDR global score equal to zero.
Key exclusion criteria (6 listed)
- (1) Any diagnosis of neurological diseases (e.g., epilepsy, stroke) made by a clinician, OR
- (2) Any diagnosis of psychiatric illnesses (e.g., depressive disorders) made by a clinician, OR
- (3) Significant sensory or motor impairments, OR
- (4) Known allergy to mushrooms or a history of serious food allergies, OR
- (5) Participants with a history of gout, OR
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 |
|---|---|---|
| Golden oyster mushroom powderParticipants in the intervention group will consume Pleurotus citrinopileatus mushroom powder daily for 24months, with compliance monitored using electronic diary apps. The powder contains 7.0 mg/g of ergothioneine (dry weight). | Dietary supplement | mushroom powder intervention arm |
Primary outcome
MMSE
Time frame: 24 months
Total scores change
7 secondary outcomes
plasma ergothioneine
Time frame: 24 months
Rey Auditory Verbal Learning Test
Time frame: 12, and 24 months
inflammatory markers
Time frame: 24 months
NfL
Time frame: 24 months
Epigenetic age
Time frame: 24 months
Symbol Digit Modality test
Time frame: 12, and 24 months
Clinical Dementia Rating
Time frame: 12, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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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.
Lei FEng principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Golden oyster mushroom powder in people with Dementia and Cognitive Assessment, run by National University of Singapore at 1 site in Singapore.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. 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 Singapore. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiatong Shan (+65 89413228, e1397079@u.nus.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2026.