Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function

NCT ID: NCT03826017

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2019-10-08

Brief Summary

This study was the efficacy and safety of Catechin high contain greentea extract on improvement of Cognitive Function

Detailed Description

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 80 subjects were participated in Catechin high contain greentea extract or placebo group. To evaluate the changes of the evaluation items when Catechin high contain greentea extract was taken 12 weeks compared with placebo.

Conditions

Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Catechin high contain greentea extract

Catechin high contain greentea extract for 260 mg/day 12 weeks.

Group Type: EXPERIMENTAL

Catechin high contain greentea extract

Intervention Type: DIETARY_SUPPLEMENT

Catechin high contain greentea extract 260 mg/day for 12 weeks.

Placebo

Placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo for 12 weeks.

Interventions

Catechin high contain greentea extract

Catechin high contain greentea extract 260 mg/day for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Those who are at least 60 years of age at screening
• Those who have Korean Mini-Mental Status Examination(K-MMSE) result 25-28 points
• Those who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial

Exclusion Criteria

• Those with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
• Those with alcohol abuse or dependence within the last 3 months
• Those who have clinically significant following severe illness (Epilepsy, mental retardation, brain nervous system diseases, endocrine diseases, blood / malignant tumors, cardiovascular diseases, Crohn's disease, etc.)
• Those with a history of clinically significant hypersensitivity to green tea
• Those taking medicines, health functional foods or herbal medicines related to improvement of cognitive function and memory within 1 month before screening
• Those who ingested green tea extract's health functional food within 1 month before screening
• Those who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
• Those who participate in other human tiral within 3 months
• Those who shows the following results in the Laboratory test

• AST, ALT > 3 times upper limit of normal range
• Other significant laboratory test opinion
• Those who is deemed unsuitable for participating in the human trial due to other reasons

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Young Chul Chung

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young-chul Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

RNO-CF-EG

Identifier Type: -

Identifier Source: org_study_id