Clinical trial NCT03826017: Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function
Official title: A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Keywords: Catechin high contain greentea extract
Cognitive Function
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes of Visual learning test
timeFrame: 12 weeks
measure: Changes of Korean Version of the Montreal Cognitive Assessment(MoCA-K)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of Auditory continuous performance test
timeFrame: 12 weeks
measure: Changes of Verbal learning test
timeFrame: 12 weeks
measure: Changes of Visual working memory test
timeFrame: 12 weeks
measure: Changes of Perceived stress scale(PSS)
timeFrame: 12 weeks
measure: Changes of Beck Depression Inventory(BDI)
timeFrame: 12 weeks
measure: Changes of Brain-derived neurotrophic factor(BDNF)
timeFrame: 12 weeks
measure: Changes of Total antioxidant status(TAS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Department of Psychiatry, Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Young-chul Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: