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Completed

NCT Number: NCT01734200

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 Memory Function. The investigators measured decrement of improvement of Memory Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood pressure.

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Key information

Conditions

Cognitive Function

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

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 16-19 years old
  • Weight within ±30% of ideal body weight
  • Able to give informed consent

Exclusion criteria

  • 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
  • Pregnant or lactating women 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).

Secondary outcomes

  1. Changes in Rey-Kim Memory Test

    Time frame: 12 weeks

    Rey-Kim Memory 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).

  3. Changes in PRMQ(Prospective and retrospective memory questionnaire)

    Time frame: 12 weeks

    PRMQ(Prospective and retrospective memory questionnaire) was measured in study visit 1(0 week) and visit 3(12 week).

  4. Changes in STAI(State-trait anxiety inventory)

    Time frame: 12 weeks

    STAI(State-trait anxiety inventory) was measured in study visit 1(0 week) and visit 3(12 week).

  5. Changes in BDNF(Brain derived neurotrophic factor)

    Time frame: 12 weeks

    BDNF(Brain derived neurotrophic factor) 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

Official study title

Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function: a 12 Week, Randomized Double-blind, Placebo-controlled Clinical Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2012
Registry last updated
Jul 15, 2015

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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