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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01734200
First received: November 22, 2012
Last updated: July 13, 2015
Last verified: July 2015
  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
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
Official Title: Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function: a 12 Week, Randomized Double-blind, Placebo-controlled Clinical Trial

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).


Secondary Outcome Measures:
  • 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).

  • 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).

  • Changes in STAI(State-trait anxiety inventory) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    STAI(State-trait anxiety inventory) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in BDNF(Brain derived neurotrophic factor) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    BDNF(Brain derived neurotrophic factor) was measured in study visit 1(0 week) and visit 3(12 week).


Enrollment: 80
Study Start Date: November 2012
Study Completion Date: November 2013
Primary Completion Date: September 2013 (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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
  More Information

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: July 13, 2015
Health Authority: South Korea: Institutional Review Board

ClinicalTrials.gov processed this record on December 08, 2016