Effect of Skate Skin Extract on Cognitive Function in Adults

NCT03849391 | Completed

• 1 other identifier: 02-2018-034
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Memory Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Korean instrumental activity of daily living total score

  Change from Baseline Korean instrumental activity of daily living total score at 3 months

• Computerized NeuroCognitive Function test total score

  Change from Baseline Computerized NeuroCognitive Function test total score at 3 months

• brain derived neurotrophic factor

  Change from Baseline brain derived neurotrophic factor level at 3 months

Study Arms (2)

Skate group

EXPERIMENTAL

This group takes Skate Skin extract for 12 weeks

Dietary Supplement: Skate group

Placebo group

PLACEBO COMPARATOR

This group takes Placebo for 12 weeks

Dietary Supplement: Placebo group

Interventions

Skate group DIETARY_SUPPLEMENT

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

Skate group

Placebo group DIETARY_SUPPLEMENT

This group takes 500 mg/day Placebo for 12 weeks

Placebo group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Global Deterioration Scale (GDS) 2 or 3

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Integrated Research Institute for Natural Ingredients and Functional Foods

Yangsan, 50612, South Korea

Location

Study Officials

• Sang Yeoup Lee, MD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: February 1, 2019
• Primary Completion: February 14, 2020
• Study Completion: February 28, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

KR (1)