Efficacy and Safety of Sesame Oil Cake 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 Sesame oil cake 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. 70 subjects were participated in Sesame Oil Cake Extract or placebo group. To evaluate the changes of the evaluation items when Sesame Oil Cake Extract was taken three times a day 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 Sesame Oil Cake Extract on Improvement of Cognitive Function

Conditions
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Cognitive Function

Intervention / Treatment
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* Dietary Supplement: Sesame Oil Cake 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 word list memory / recollection/ recognition test scores of CERAD -K decrease 1-2 SD number of normal value 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 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 take any prescription medicines or herbal medicines within 2 weeks before the first ingestion date or take any OTC or vitamin preparations within 1 week Those who participate in other human trial within 2 months before the first ingestion Those who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks 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: Sesame Oil Cake Extract<br>Sesame Oil Cake Extract 1.5 g/day for 12 weeks | Dietary Supplement: Sesame Oil Cake Extract<br>* Sesame Oil Cake Extract 1.5 g/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 weeks. | 12 weeks | 
| Changes of Visual working memory test | Visual working memory test was measured in baseline and 12 weeks. | 12 weeks | 
| Changes of Verbal learning test | Verbal learning test was measured in baseline and 12 weeks. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the Montreal Cognitive Assessment(MoCA-K) | 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. It takes about 10 minutes to complete, and the score is 30 points. 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 | 
| Changes of beta-amyloid | Beta-amyloid(pg/mL) was measured in baseline and 12 weeks. | 12 weeks | 
| Changes of Oxidation index(8-OHdG) | Oxidation index(8-OHdG)(ng/mL) was measured in baseline and 12 weeks. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Function, Sesam Esamesame Oil Cake