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Completed

NCT Number: NCT03849391

Effect of Skate Skin Extract on Cognitive Function in Adults

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrated Research Institute for Natural Ingredients and Functional Foods

Yangsan, 50612, South Korea

About this study

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;

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skate group

Dietary Supplement

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

Placebo Group

Dietary Supplement

This group takes 500 mg/day Placebo for 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2019
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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