Effect of Skate Skin Extract on Cognitive Function in Adults

Pusan National University Yangsan Hospital100 enrolled

Overview

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.

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;

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Subjective Memory Impairment

Interventions

Skate groupDIETARY_SUPPLEMENT

This group takes 500 mg/day Skate Skin extract for 12 weeks

Placebo groupDIETARY_SUPPLEMENT

This group takes 500 mg/day Placebo for 12 weeks

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Integrated Research Institute for Natural Ingredients and Functional Foods

Yangsan, South Korea

Outcomes

Primary Outcomes

Mini-Mental State Examination total score

Change in Mini-Mental State Examination total score during 3 months

Time frame: Change from Baseline Mini-Mental State Examination total score at 3 months

Secondary Outcomes

Korean instrumental activity of daily living total score

Change in Korean instrumental activity of daily living total score during 3 months

Time frame: 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

Time frame: 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

Time frame: Change from Baseline brain derived neurotrophic factor level at 3 months

Data from ClinicalTrials.gov

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