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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorNational University of Singapore

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 volunteers

Qualifiers

(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

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: mushroom powder intervention armExperimental treatment 1 intervention
Group B: Placebo armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

MMSE

Total scores change

Time frame
24 months

Secondary outcomes

1

plasma ergothioneine

Time frame
24 months
2

Rey Auditory Verbal Learning Test

Time frame
12, and 24 months
3

inflammatory markers

hs-CRP, TNFα, IL-1, IL-6, and etc

Time frame
24 months
4

NfL

Time frame
24 months

Other outcomes

Sponsors and contacts

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