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

This study is currently recruiting participants.
Verified November 2012 by Chonbuk National University Hospital
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01734213
First received: November 22, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Cognitive Function
 Dietary Supplement: Eriobotyra Japonica Lindley Extract
Dietary Supplement: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Memory
U.S. FDA Resources

Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in K-MMSE(Korean Mini-Mental State Examination) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    K-MMSE(Korean Mini-Mental State Examination) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in ability to perform working memory tasks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Ability to perform working memory tasks was measured in study visit 1(0 week) and visit 3(12 week).


Secondary Outcome Measures:
  • Changes in CNT(Computerized neurocognitive function test) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    CNT(Computerized neurocognitive function test) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in BCRS(Brief Cognitive Rating Scale) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    BCRS(Brief Cognitive Rating Scale) was measured in study visit 1(0 week) and visit 3(12 week).


Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eriobotyra Japonica Lindley Extract Dietary Supplement: Eriobotyra Japonica Lindley Extract
Eriobotyra Japonica Lindley Extract (1.5g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (1.5g/day)

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734213

Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Myoung-Hwan Ko, MD., PhD     82-63-250-1795     mhko@jbnu.ac.kr    
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01734213     History of Changes
Other Study ID Numbers: JINR-COG-ERIO
Study First Received: November 22, 2012
Last Updated: November 26, 2012
Health Authority: South Korea: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013