Effect of Skate Skin Extract on Cognitive Function in Adults

Not Applicable

Completed

• Conditions: Subjective Memory Impairment
• Interventions: Dietary Supplement: Skate group; Dietary Supplement: Placebo group

• Registration Number: NCT03849391
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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

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 Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skate group	Skate group	This group takes Skate Skin extract for 12 weeks
Placebo group	Placebo group	This group takes Placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mini-Mental State Examination total score	Change from Baseline Mini-Mental State Examination total score at 3 months	Change in Mini-Mental State Examination total score during 3 months

Secondary Outcome Measures

Name	Time	Method
Korean instrumental activity of daily living total score	Change from Baseline Korean instrumental activity of daily living total score at 3 months	Change in Korean instrumental activity of daily living total score during 3 months
Computerized NeuroCognitive Function test total score	Change from Baseline Computerized NeuroCognitive Function test total score at 3 months	Change in Computerized NeuroCognitive Function test total score during 3 months
brain derived neurotrophic factor	Change from Baseline brain derived neurotrophic factor level at 3 months	Change in brain derived neurotrophic factor level during 3 months

Trial Locations

Locations (1)

Integrated Research Institute for Natural Ingredients and Functional Foods; 🇰🇷 Yangsan, Korea, Republic of