Effect of Skate Skin Extract on Cognitive Function in Adults

Subjective Memory Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849391
• Other study ID #: 02-2018-034
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: March 2020
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Memory Disorders
• Subjective Memory Impairment

Intervention

Dietary Supplement:
• Skate group
This group takes 500 mg/day Skate Skin extract for 12 weeks
• Placebo group
This group takes 500 mg/day Placebo for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Integrated Research Institute for Natural Ingredients and Functional Foods	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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