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Effect of Skate Skin Extract on Cognitive Function in Adults

Primary Purpose

Subjective Memory Impairment

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Skate group

Placebo group

About this trial

This is an interventional treatment trial for Subjective Memory Impairment

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Integrated Research Institute for Natural Ingredients and Functional Foods

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Skate group

Placebo group

Arm Description

This group takes Skate Skin extract for 12 weeks

This group takes Placebo for 12 weeks

Outcomes

Primary Outcome Measures

Mini-Mental State Examination total score

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

Secondary Outcome Measures

Korean instrumental activity of daily living total score

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

Computerized NeuroCognitive Function test total score

Change in Computerized NeuroCognitive Function test total score during 3 months

brain derived neurotrophic factor

Change in brain derived neurotrophic factor level during 3 months

Full Information

NCT ID

NCT03849391

First Posted

February 19, 2019

Last Updated

March 2, 2020

Sponsor

Pusan National University Yangsan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03849391

Brief Title

Effect of Skate Skin Extract on Cognitive Function in Adults

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

February 14, 2020 (Actual)

Study Completion Date

February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subjective Memory Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Skate group

Arm Type

Experimental

Arm Description

This group takes Skate Skin extract for 12 weeks

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

This group takes Placebo for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Skate group

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo group

Intervention Description

This group takes 500 mg/day Placebo for 12 weeks

Primary Outcome Measure Information:

Title

Mini-Mental State Examination total score

Description

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 Outcome Measure Information:

Title

Korean instrumental activity of daily living total score

Description

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

Title

Computerized NeuroCognitive Function test total score

Description

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

Title

brain derived neurotrophic factor

Description

Change in brain derived neurotrophic factor level during 3 months

Time Frame

Change from Baseline brain derived neurotrophic factor level at 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sang Yeoup Lee, MD

Organizational Affiliation

Pusan National University Yangsan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Integrated Research Institute for Natural Ingredients and Functional Foods

City

Yangsan

ZIP/Postal Code

50612

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Effect of Skate Skin Extract on Cognitive Function in Adults

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