Study Protocol: The Efficacy of Mushroom to Reduce Cognitive Decline in At-Risk Middle-aged Adults and Young-olds Living in the Community
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- MMSE
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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.
排除标准
- •(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.
研究组 & 干预措施
Placebo arm
mushroom powder intervention arm
干预措施: Golden oyster mushroom powder (Dietary Supplement)
结局指标
主要结局
MMSE
时间窗: 24 months
Total scores change
次要结局
- Clinical Dementia Rating(12, and 24 months)
- plasma ergothioneine(24 months)
- Rey Auditory Verbal Learning Test(12, and 24 months)
- NfL(24 months)
- Epigenetic age(24 months)
- Symbol Digit Modality test(12, and 24 months)
- inflammatory markers(24 months)
研究者
Feng Lei
Assistant Professor
National University of Singapore