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NCT Number: NCT07775833

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

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

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Cognitive Assessment Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Singapore, 117549

Location status: Recruiting

Location contact

Kai Xuan Lim

CONTACT

[email protected]

+65 90553343

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

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).

Primary outcomes

  1. MMSE

    Time frame: 24 months

    Total scores change

Secondary outcomes

  1. plasma ergothioneine

    Time frame: 24 months

  2. Rey Auditory Verbal Learning Test

    Time frame: 12, and 24 months

  3. inflammatory markers

    Time frame: 24 months

  4. NfL

    Time frame: 24 months

  5. Epigenetic age

    Time frame: 24 months

  6. Symbol Digit Modality test

    Time frame: 12, and 24 months

  7. Clinical Dementia Rating

    Time frame: 12, and 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jiatong Shan

CONTACT

[email protected]

+65 89413228

Kai Xuan Lim

CONTACT

[email protected]

+65 90553343

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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