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

Cognitive Function Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826017
• Other study ID #: RNO-CF-EG
• Status: Completed
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: October 8, 2019

Study information

• Verified date: July 2020
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 8, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function

Intervention

Dietary Supplement:
• Catechin high contain greentea extract
Catechin high contain greentea extract 260 mg/day for 12 weeks.
• Placebo
Placebo for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Department of Psychiatry, 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 of Visual learning test	Visual learning test was measured in baseline and 12 week.	12 weeks
Primary	Changes of Korean Version of the Montreal Cognitive Assessment(MoCA-K)	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.	12 weeks
Secondary	Changes of Auditory continuous performance test	Auditory continuous performance test was measured in baseline and 12 week.	12 weeks
Secondary	Changes of Verbal learning test	Verbal learning test was measured in baseline and 12 week.	12 weeks
Secondary	Changes of Visual working memory test	Visual working memory test was measured in baseline and 12 week.	12 weeks
Secondary	Changes of Perceived stress scale(PSS)	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).	12 weeks
Secondary	Changes of Beck Depression Inventory(BDI)	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.	12 weeks
Secondary	Changes of Brain-derived neurotrophic factor(BDNF)	Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.	12 weeks
Secondary	Changes of Total antioxidant status(TAS)	Total antioxidant status(TAS) was measured in baseline and 12 week.	12 weeks