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

Chonbuk National University

Status

Completed

Conditions

Cognitive Function

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Catechin high contain greentea extract

Study type

Interventional

Funder types

Other

Identifiers

NCT03826017

RNO-CF-EG

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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