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Effect of Skate Skin Extract on Cognitive Function in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03849391
Recruitment Status : Completed
First Posted : February 21, 2019
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, Pusan National University Yangsan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Subjective Memory Impairment Dietary Supplement: Skate group Dietary Supplement: Placebo group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Skate Skin Extract on Cognitive Function in Adults With Subjective Memory Impairment
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : February 14, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Mini-Mental State Examination total score [ Time Frame: 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 :
  1. Korean instrumental activity of daily living total score [ Time Frame: 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

  2. Computerized NeuroCognitive Function test total score [ Time Frame: Change from Baseline Computerized NeuroCognitive Function test total score at 3 months ]
    Change in Computerized NeuroCognitive Function test total score during 3 months

  3. brain derived neurotrophic factor [ Time Frame: Change from Baseline brain derived neurotrophic factor level at 3 months ]
    Change in brain derived neurotrophic factor level during 3 months


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849391


Locations
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Korea, Republic of
Integrated Research Institute for Natural Ingredients and Functional Foods
Yangsan, Korea, Republic of, 50612
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Sang Yeoup Lee, MD Pusan National University Yangsan Hospital
More Information
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Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT03849391    
Other Study ID Numbers: 02-2018-034
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases