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

Cognitive Function Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734213
• Other study ID #: JINR-COG-ERIO
• Status: Completed
• Phase: N/A
• Start date: May 10, 2012
• Est. completion date: October 15, 2013

Study information

• Verified date: August 2019
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 15, 2013
• Est. primary completion date: October 15, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Dietary Supplement:
• Eriobotyra Japonica Lindley Extract
Eriobotyra Japonica Lindley Extract (1.5g/day)
• Placebo
Placebo (1.5g/day)

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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