Effect of Skate Skin Extract on Cognitive Function in Adults

Study Overview
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Brief Summary
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The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks.

Detailed Description
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Previous animal studies have indicated that Skate Skin extract may have the ability to improve cognitive function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Skate Skin extract on cognitive function in adults with subjective memory impairment for 12 weeks; the safety of the compound are also evaluate. The Investigators examine chemical and metabolic parameters, and cognitive function at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 500 mg of Skate Skin extract or a placebo each day for 12 weeks;

Official Title
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Effect of Skate Skin Extract on Cognitive Function in Adults With Subjective Memory Impairment

Conditions
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Subjective Memory Impairment

Intervention / Treatment
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* Dietary Supplement: Skate group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Global Deterioration Scale (GDS) 2 or 3 Exclusion Criteria: Abnormal liver or renal function (i.e., serum aminotransferase activity > 3 times of upper limit of reference range and serum creatinine concentrations > 1.2 mg/dL) Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL) History of viral hepatitis or cancer Uncontrolled hypertension History of serious cardiac disease such as angina or myocardial infarction History of gastrectomy History of medication for psychiatric disease Administration of oriental medicine including herbs within the past 4 weeks

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skate group<br>This group takes Skate Skin extract for 12 weeks | Dietary Supplement: Skate group<br>* This group takes 500 mg/day Skate Skin extract for 12 weeks<br>|
| Placebo Comparator: Placebo group<br>This group takes Placebo for 12 weeks | Dietary Supplement: Placebo group<br>* This group takes 500 mg/day Placebo for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination total score | Change in Mini-Mental State Examination total score during 3 months | Change from Baseline Mini-Mental State Examination total score at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean instrumental activity of daily living total score | Change in Korean instrumental activity of daily living total score during 3 months | Change from Baseline Korean instrumental activity of daily living total score at 3 months | 
| Computerized NeuroCognitive Function test total score | Change in Computerized NeuroCognitive Function test total score during 3 months | Change from Baseline Computerized NeuroCognitive Function test total score at 3 months | 
| brain derived neurotrophic factor | Change in brain derived neurotrophic factor level during 3 months | Change from Baseline brain derived neurotrophic factor level at 3 months |