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

Cognitive Function Clinical Trial

Official title:

Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function: a 12 Week, Randomized Double-blind, Placebo-controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734200
• Other study ID #: INs-MF-ERIO
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 22, 2012
• Last updated: July 13, 2015
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: July 2015
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 19 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

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