Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Memory 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:
NCT01734200
First received: November 22, 2012
Last updated: November 26, 2012
Last verified: November 2012
  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 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.


Condition Intervention Phase
Memory 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:


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 Rey-Kim Memory Test [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Rey-Kim Memory Test was measured in study visit 1(0 week) and visit 3(12 week).


Secondary Outcome Measures:
  • 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).

  • Changes in PRMQ(Prospective and retrospective memory questionnaire) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    PRMQ(Prospective and retrospective memory questionnaire) was measured in study visit 1(0 week) and visit 3(12 week).


Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Primary Completion Date: November 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:   16 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734200

Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Soo-Wan Chae, MD., PhD    82-63-250-2539    soowan@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: NCT01734200     History of Changes
Other Study ID Numbers: INs-MF-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 April 17, 2014