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

Not Applicable

Completed

• Conditions: Cognitive Function
• Interventions: Dietary Supplement: Eriobotyra Japonica Lindley Extract; Dietary Supplement: Placebo

• Registration Number: NCT01734213
• Lead Sponsor: Chonbuk National University Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-10
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-22
• Study First Posted: 2012-11-27
• Primary Completion: 2013-10-15
• Study Completion: 2013-10-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-29
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eriobotyra Japonica Lindley Extract	Eriobotyra Japonica Lindley Extract	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in K-MMSE(Korean Mini-Mental State Examination)	12 weeks	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	12 weeks	Ability to perform working memory tasks was measured in study visit 1(0 week) and visit 3(12 week).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of