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

Phase 2

Completed

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

• Registration Number: NCT01734200
• 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 Memory Function. The investigators measured decrement of improvement of Memory Function, including K-MMSE, Rey-Kim Memory Test, BCRS, and PRMQ, and monitored their blood pressure.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-22
• Study First Posted: 2012-11-27
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-13
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Males and females 16-19 years old
• Weight within ±30% of ideal body weight
• Able to give informed consent

Exclusion Criteria

• 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
• Pregnant or lactating women 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).

Secondary Outcome Measures

Name	Time	Method
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).
Changes in Rey-Kim Memory Test	12 weeks	Rey-Kim Memory Test was measured in study visit 1(0 week) and visit 3(12 week).
Changes in PRMQ(Prospective and retrospective memory questionnaire)	12 weeks	PRMQ(Prospective and retrospective memory questionnaire) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in STAI(State-trait anxiety inventory)	12 weeks	STAI(State-trait anxiety inventory) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in BDNF(Brain derived neurotrophic factor)	12 weeks	BDNF(Brain derived neurotrophic factor) 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