Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 22, 2012
CompletedFirst Posted
Study publicly available on registry
November 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJuly 15, 2015
July 1, 2015
10 months
November 22, 2012
July 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in K-MMSE(Korean Mini-Mental State Examination)
K-MMSE(Korean Mini-Mental State Examination) was measured in study visit 1(0 week) and visit 3(12 week).
12 weeks
Secondary Outcomes (5)
Changes in Rey-Kim Memory Test
12 weeks
Changes in BCRS(Brief Cognitive Rating Scale)
12 weeks
Changes in PRMQ(Prospective and retrospective memory questionnaire)
12 weeks
Changes in STAI(State-trait anxiety inventory)
12 weeks
Changes in BDNF(Brain derived neurotrophic factor)
12 weeks
Study Arms (2)
Eriobotyra Japonica Lindley Extract
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eriobotyra Japonica Lindley Extract (1.5g/day)
Eligibility Criteria
You may qualify if:
- Males and females 16-19 years old
- Weight within ±30% of ideal body weight
- Able to give informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical Trial Center for Functional Foods
Study Record Dates
First Submitted
November 22, 2012
First Posted
November 27, 2012
Study Start
November 1, 2012
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
July 15, 2015
Record last verified: 2015-07