Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function

Study Overview
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Brief Summary
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This study was the efficacy and safety of Catechin high contain greentea extract on improvement of Cognitive Function

Detailed Description
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This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 80 subjects were participated in Catechin high contain greentea extract or placebo group. To evaluate the changes of the evaluation items when Catechin high contain greentea extract was taken 12 weeks compared with placebo.

Official Title
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A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function

Conditions
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Cognitive Function

Intervention / Treatment
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* Dietary Supplement: Catechin high contain greentea extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who are at least 60 years of age at screening Those who have Korean Mini-Mental Status Examination(K-MMSE) result 25-28 points Those who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial Exclusion Criteria: Those with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years Those with alcohol abuse or dependence within the last 3 months Those who have clinically significant following severe illness (Epilepsy, mental retardation, brain nervous system diseases, endocrine diseases, blood / malignant tumors, cardiovascular diseases, Crohn's disease, etc.) Those with a history of clinically significant hypersensitivity to green tea Those taking medicines, health functional foods or herbal medicines related to improvement of cognitive function and memory within 1 month before screening Those who ingested green tea extract's health functional food within 1 month before screening Those who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks Those who participate in other human tiral within 3 months Those who shows the following results in the Laboratory test AST, ALT > 3 times upper limit of normal range Other significant laboratory test opinion Those who is deemed unsuitable for participating in the human trial due to other reasons

Ages Eligible for Study
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Minimum Age: 60 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: Catechin high contain greentea extract<br>Catechin high contain greentea extract for 260 mg/day 12 weeks. | Dietary Supplement: Catechin high contain greentea extract<br>* Catechin high contain greentea extract 260 mg/day for 12 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo for 12 weeks. | Dietary Supplement: Placebo<br>* Placebo for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Visual learning test | Visual learning test was measured in baseline and 12 week. | 12 weeks | 
| Changes of Korean Version of the Montreal Cognitive Assessment(MoCA-K) | Korean Version of the Montreal Cognitive Assessment(MoCA-K) was measured in baseline and 12 week. The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation. Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Auditory continuous performance test | Auditory continuous performance test was measured in baseline and 12 week. | 12 weeks | 
| Changes of Verbal learning test | Verbal learning test was measured in baseline and 12 week. | 12 weeks | 
| Changes of Visual working memory test | Visual working memory test was measured in baseline and 12 week. | 12 weeks | 
| Changes of Perceived stress scale(PSS) | Perceived stress scale(PSS) was measured in baseline and 12 week. It consists of 10 questions. Each question is evaluated from 0 (none) to 4 (very often), and 4 items (4, 5, 7, 8) are scored back and added to the remaining questions. The duration of the last month should be presented before implementation (if the duration is longer, the predictability is lowered). | 12 weeks | 
| Changes of Beck Depression Inventory(BDI) | Beck Depression Inventory(BDI) was measured in baseline and 12 week. It consists of 21 items including cognitive, emotional, synchronous, and physical symptoms of depression. The total score ranges from 0 63 points for each question. Beck Depression Inventory(BDI) score is 0   9 points non-depression, 10   15 is mild depression, 16   23 is moderate depression, and 24   63 is severe depression. | 12 weeks | 
| Changes of Brain-derived neurotrophic factor(BDNF) | Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week. | 12 weeks | 
| Changes of Total antioxidant status(TAS) | Total antioxidant status(TAS) was measured in baseline and 12 week. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catechin high contain greentea extract, Cognitive Function