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 Memory Function. The investigators measured decrement of improvement of Memory Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood pressure.

Official Title
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Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function: a 12 Week, Randomized Double-blind, Placebo-controlled Clinical Trial

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 16-19 years old Weight within ±30% of ideal body weight Able to give informed consent Exclusion Criteria: 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 Pregnant or lactating women etc.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 19 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Rey-Kim Memory Test | Rey-Kim Memory 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 | 
| Changes in PRMQ(Prospective and retrospective memory questionnaire) | PRMQ(Prospective and retrospective memory questionnaire) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in STAI(State-trait anxiety inventory) | STAI(State-trait anxiety inventory) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in BDNF(Brain derived neurotrophic factor) | BDNF(Brain derived neurotrophic factor) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks |