Effect of Skate Skin Extract on Cognitive Function in Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Subjective Memory Impairment
• Intervention / Treatment: Dietary supplement: Skate group; Dietary supplement: Placebo group

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan, Korea, Republic of, 50612
    • Integrated Research Institute for Natural Ingredients and Functional Foods

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skate group; This group takes Skate Skin extract for 12 weeks	Dietary supplement: Skate group; This group takes 500 mg/day Skate Skin extract for 12 weeks
Placebo Comparator: Placebo group; This group takes Placebo for 12 weeks	Dietary supplement: Placebo group; This group takes 500 mg/day Placebo for 12 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 14, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Memory Disorders
• Other Study ID Numbers: 02-2018-034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No