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

Not Applicable

Completed

• Conditions: Cognitive Function

• Registration Number: NCT03826017
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2018-12-05
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Primary Completion: 2019-10-08
• Study Completion: 2019-10-08
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of Korean Version of the Montreal Cognitive Assessment(MoCA-K)	12 weeks	Korean Version of the Montreal Cognitive Assessment(MoCA-K) was measured in baseline and 12 week. The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation.; Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.
Changes of Visual learning test	12 weeks	Visual learning test was measured in baseline and 12 week.

Secondary Outcome Measures

Name	Time	Method
Changes of Verbal learning test	12 weeks	Verbal learning test was measured in baseline and 12 week.
Changes of Visual working memory test	12 weeks	Visual working memory test was measured in baseline and 12 week.
Changes of Perceived stress scale(PSS)	12 weeks	Perceived stress scale(PSS) was measured in baseline and 12 week. It consists of 10 questions. Each question is evaluated from 0 (none) to 4 (very often), and 4 items (4, 5, 7, 8) are scored back and added to the remaining questions. The duration of the last month should be presented before implementation (if the duration is longer, the predictability is lowered).
Changes of Brain-derived neurotrophic factor(BDNF)	12 weeks	Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.
Changes of Total antioxidant status(TAS)	12 weeks	Total antioxidant status(TAS) was measured in baseline and 12 week.
Changes of Beck Depression Inventory(BDI)	12 weeks	Beck Depression Inventory(BDI) was measured in baseline and 12 week. It consists of 21 items including cognitive, emotional, synchronous, and physical symptoms of depression. The total score ranges from 0\~63 points for each question. Beck Depression Inventory(BDI) score is 0 \~ 9 points non-depression, 10 \~ 15 is mild depression, 16 \~ 23 is moderate depression, and 24 \~ 63 is severe depression.
Changes of Auditory continuous performance test	12 weeks	Auditory continuous performance test was measured in baseline and 12 week.

Trial Locations

Locations (1)

Department of Psychiatry, Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of