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 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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Dietary supplement: Eriobotyra Japonica Lindley Extract; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo (1.5g/day)
Experimental: Eriobotyra Japonica Lindley Extract	Dietary supplement: Eriobotyra Japonica Lindley Extract; Eriobotyra Japonica Lindley Extract (1.5g/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in ability to perform working memory tasks	Ability to perform working memory tasks was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in CNT(Computerized neurocognitive function test)	CNT(Computerized neurocognitive function test) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Changes in BCRS(Brief Cognitive Rating Scale)	BCRS(Brief Cognitive Rating Scale) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2012
• Primary Completion (Actual): October 15, 2013
• Study Completion (Actual): October 15, 2013

Study Registration Dates

• First Submitted: November 22, 2012
• First Submitted That Met QC Criteria: November 22, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: JINR-COG-ERIO