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

NCT01734213 | Completed DMC

• 1 other identifier: JINR-COG-ERIO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 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 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.

Conditions

Cognitive Function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes in CNT(Computerized neurocognitive function test)

  12 weeks

• Changes in BCRS(Brief Cognitive Rating Scale)

  12 weeks

Study Arms (2)

Eriobotyra Japonica Lindley Extract

EXPERIMENTAL

Dietary Supplement: Eriobotyra Japonica Lindley Extract

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Eriobotyra Japonica Lindley Extract DIETARY_SUPPLEMENT

Eriobotyra Japonica Lindley Extract (1.5g/day)

Eriobotyra Japonica Lindley Extract

Placebo DIETARY_SUPPLEMENT

Placebo (1.5g/day)

Placebo

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Males and females ≥ 65 years old
• Able to give informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: May 10, 2012
• Primary Completion: October 15, 2013
• Study Completion: October 15, 2013
• Last Updated: September 3, 2019

Record last verified: 2019-08

Locations

KR (1)