About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
(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.
Disqualifiers
(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
Trial design
Parallel
Treatments tested in this trial
Golden oyster mushroom powder
Dietary supplementParticipants 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).
Treatment groups
Trial outcomes
Primary outcomes
MMSE
Total scores change
Secondary outcomes
plasma ergothioneine
Rey Auditory Verbal Learning Test
inflammatory markers
hs-CRP, TNFα, IL-1, IL-6, and etc
NfL
Sponsors and contacts
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