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

Chonbuk National University Hospital60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Cognitive Function

Interventions

Eriobotyra Japonica Lindley ExtractDIETARY_SUPPLEMENT

Eriobotyra Japonica Lindley Extract (1.5g/day)

PlaceboDIETARY_SUPPLEMENT

Placebo (1.5g/day)

Eligibility

Sex: ALLMin age: 65 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 12 weeks

Secondary Outcomes

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).

Time frame: 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).

Time frame: 12 weeks

Data from ClinicalTrials.gov

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