Study Protocol: The Efficacy of Mushroom to Reduce Cognitive Decline in At-Risk Middle-aged Adults and Young-olds Living in the Community

NCT07775833 | Recruiting

• 1 other identifier: NUS-IRB-2025-118
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• MMSE

  Total scores change

  24 months

Secondary Outcomes (7)

• plasma ergothioneine

  24 months

• Rey Auditory Verbal Learning Test

  12, and 24 months

• inflammatory markers

  24 months

• NfL

  24 months

• Epigenetic age

  24 months

Study Arms (2)

mushroom powder intervention arm

EXPERIMENTAL

Dietary Supplement: Golden oyster mushroom powder

Placebo arm

NO INTERVENTION

Interventions

Golden oyster mushroom powder DIETARY_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).

mushroom powder intervention arm

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

Tahir Foundation Building, MD1, Level 12 (12 Science Drive 2)

Singapore, 117549, Singapore

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lei FEng

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiatong Shan

CONTACT

+65 89413228; e1397079@u.nus.edu

Kai Xuan Lim

CONTACT

+65 90553343; kaixuan@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: August 20, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 1, 2026

Record last verified: 2026-04

Locations

SG (1)