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

National University of Singapore600 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

600

Conditions

Dementia Cognitive Assessment

Interventions

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

MMSE

Total scores change

Time frame: 24 months

Secondary Outcomes

plasma ergothioneine

Time frame: 24 months

Rey Auditory Verbal Learning Test

Time frame: 12, and 24 months

inflammatory markers

hs-CRP, TNFα, IL-1, IL-6, and etc

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts