Cognitive Assessment, Dementia
Conditions
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
Interventions
DIETARY_SUPPLEMENTGolden oyster mushroom powder
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).
Sponsors
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MMSE | 24 months | Total scores change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory markers | 24 months | hs-CRP, TNFα, IL-1, IL-6, and etc |
| NfL | 24 months | — |
| Epigenetic age | 24 months | — |
| Symbol Digit Modality test | 12, and 24 months | — |
| Clinical Dementia Rating | 12, and 24 months | — |
| Rey Auditory Verbal Learning Test | 12, and 24 months | — |
| plasma ergothioneine | 24 months | — |
Countries
Singapore
Contacts
CONTACTJiatong Shan
CONTACTKai Xuan Lim
PRINCIPAL_INVESTIGATORLei FEng
National University of Singapore
Outcome results
None listed