NCT05962008已完成不适用
Effects of Consumption of Phosphatidylserine on the Cognitive Function: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- The measured value of the standardized score of composite memory at Week 12
研究概览
简要总结
The main objective of this trial is to verify the effects of consumption of phosphatidylserine for 12 weeks on the cognitive function in healthy Japanese subjects.
详细描述
In this study, the investigators will evaluate the cognitive function before and after the intervention. The groups to be compared are omega-3-phosphatidylserine derived from herring roe, phosphatidylserine derived from soybean, and a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female
- •Subjects aged 35-65
- •Healthy subjects
- •Subjects who notice a decline in memory
- •Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more
- •Subjects who met the inclusion criteria
- •and have relatively low standardized score in composite memory measured using Cognitrax at Scr (Selection of those with relatively low standardized scores will be conducted in blocks of "Subjects aged 50 or over" and "Subjects aged under 50")
- •Subjects who are judged as eligible to participate in the study by the physician
排除标准
- •Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction
- •Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)
- •Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
- •Subjects who have dementia
- •Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues
- •Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage, as part of their daily intake
- •Subjects who take supplements or foods that may improve cognitive functions, such as phosphatidylserine, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid (GABA), and plasmalogen, as part of their daily intake
- •Subjects who take blue-backed fish such as sardines, mackerel, and saury for 4 days/week or over
- •Subjects who use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) as part of their daily life
- •Subjects regularly taking medications (including herbal medicines) and supplements
- •Subjects who are allergic to medications and/or the test food related products
- •Subjects who are pregnant, breast-feeding or planning for pregnancy during the trial period
- •Subjects who have been enrolled in other clinical trials 28 days before the agreement to participate in this trial or those who plan to enroll in another clinical trial during the trial period
- •Subjects who are deemed ineligible to participate by the principal investigator
结局指标
主要结局
The measured value of the standardized score of composite memory at Week 12
时间窗: Week 12
Verbal Memory (VBM) test and Visual Memory (VIM) test are measured using Cognitrax® which is powered by CNS Vital Signs®, a neurocognitive test system. The standardized score of composite memory is calculated from results of these two tests. This score has been normalized with a mean of 100 and a standard deviation of 15 based on age-matched reference data. Higher scores are always better.
次要结局
- The measured value of the standardized score of neurocognition index (NCI) at Week 12(Week 12)
- The measured value of the standardized score of verbal memory at Week 12(Week 12)
- The amount of change of the standardized score of verbal memory between Base line and Week 12(Base line and Week 12)
- The measured value of the standardized score of visual memory at Week 12(Week 12)
- The amount of change of the standardized score of visual memory between Base line and Week 12(Base line and Week 12)
- The amount of change of the standardized score of composite memory between Base line and Week 12(Base line and Week 12)
- The amount of change of the standardized score of NCI between Base line and Week 12(Base line and Week 12)
- The amount of change of the standardized score of psychomotor speed between Base line and Week 12(Base line and Week 12)
- The measured value of the standardized score of reaction time at Week 12(Week 12)
- The amount of change of the standardized score of reaction time between Base line and Week 12(Base line and Week 12)
- The amount of change of the standardized score of cognitive flexibility between Base line and Week 12(Base line and Week 12)
- The amount of change of the standardized score of processing speed between Base line and Week 12(Base line and Week 12)
- The measured value of the standardized score of complex attention at Week 12(Week 12)
- The amount of change of the standardized score of complex attention between Base line and Week 12(Base line and Week 12)
- The measured value of the standardized score of processing speed at Week 12(Week 12)
- The measured value of the standardized score of social acuity at Week 12(Week 12)
- The measured value of the standardized score of reasoning at Week 12(Week 12)
- The measured value of the standardized score of psychomotor speed at Week 12(Week 12)
- The measured value of the standardized score of executive function at Week 12(Week 12)
- The amount of change of the standardized score of reasoning between Base line and Week 12(Base line and Week 12)
- The amount of change of the standardized score of simple attention between Base line and Week 12(Base line and Week 12)
- The measured value of the standardized score of motor speed at Week 12(Week 12)
- The measured value of the standardized score of cognitive flexibility at Week 12(Week 12)
- The measured value of the standardized score of working memory at Week 12(Week 12)
- The measured value of the standardized score of simple attention at Week 12(Week 12)
- The amount of change of the standardized score of social acuity between Base line and Week 12(Base line and Week 12)
- The amount of change of the standardized score of executive function between Base line and Week 12(Base line and Week 12)
- The amount of change of the standardized score of working memory between Base line and Week 12(Base line and Week 12)
- The measured value of the standardized score of sustained attention at Week 12(Week 12)
- The amount of change of the standardized score of sustained attention between Base line and Week 12(Base line and Week 12)
- The amount of change of the standardized score of motor speed between Base line and Week 12(Base line and Week 12)
研究者
研究点 (4)
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