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Completed

NCT Number: NCT01734213

Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Cognitive Function. The investigators measured improvement of Cognitive Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and BCRS, and monitored their blood pressure.

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Key information

Conditions

Cognitive Function

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females ≥ 65 years old
  • Able to give informed consent

Exclusion criteria

  • History of underlying neurodegenerative disease such as Alzheimer's disease, and Parkinson's disease
  • Subjects with medical conditions such as Severe Dementia
  • Allergic or hypersensitive to any of the ingredients in the test products
  • History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
  • History of alcohol or substance abuse
  • Participation in any other clinical trials within past 2 months
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study etc.

Treatment and study plan

Eriobotyra Japonica Lindley Extract

Dietary Supplement

Eriobotyra Japonica Lindley Extract (1.5g/day)

Placebo

Dietary Supplement

Placebo (1.5g/day)

Primary outcomes

  1. Changes in K-MMSE(Korean Mini-Mental State Examination)

    Time frame: 12 weeks

    K-MMSE(Korean Mini-Mental State Examination) was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in ability to perform working memory tasks

    Time frame: 12 weeks

    Ability to perform working memory tasks was measured in study visit 1(0 week) and visit 3(12 week).

Secondary outcomes

  1. Changes in CNT(Computerized neurocognitive function test)

    Time frame: 12 weeks

    CNT(Computerized neurocognitive function test) was measured in study visit 1(0 week) and visit 3(12 week).

  2. Changes in BCRS(Brief Cognitive Rating Scale)

    Time frame: 12 weeks

    BCRS(Brief Cognitive Rating Scale) was measured in study visit 1(0 week) and visit 3(12 week).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2012
Registry last updated
Sep 3, 2019

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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