Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function

Study Overview
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Brief Summary
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The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Cognitive Function. The investigators measured improvement of Cognitive Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and BCRS, and monitored their blood pressure.

Conditions
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Cognitive Function

Intervention / Treatment
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* Dietary Supplement: Eriobotyra Japonica Lindley Extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females ≥ 65 years old Able to give informed consent Exclusion Criteria: History of underlying neurodegenerative disease such as Alzheimer's disease, and Parkinson's disease Subjects with medical conditions such as Severe Dementia Allergic or hypersensitive to any of the ingredients in the test products History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study etc.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eriobotyra Japonica Lindley Extract<br> | Dietary Supplement: Eriobotyra Japonica Lindley Extract<br>* Eriobotyra Japonica Lindley Extract (1.5g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo (1.5g/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in K-MMSE(Korean Mini-Mental State Examination) | K-MMSE(Korean Mini-Mental State Examination) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in ability to perform working memory tasks | Ability to perform working memory tasks was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CNT(Computerized neurocognitive function test) | CNT(Computerized neurocognitive function test) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in BCRS(Brief Cognitive Rating Scale) | BCRS(Brief Cognitive Rating Scale) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks |