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

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

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

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Dietary supplement: Catechin high contain greentea extract; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Department of Psychiatry, Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catechin high contain greentea extract; Catechin high contain greentea extract for 260 mg/day 12 weeks.	Dietary supplement: Catechin high contain greentea extract; Catechin high contain greentea extract 260 mg/day for 12 weeks.
Placebo Comparator: Placebo; Placebo for 12 weeks.	Dietary supplement: Placebo; Placebo for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Visual learning test	Visual learning test was measured in baseline and 12 week.	12 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Auditory continuous performance test	Auditory continuous performance test was measured in baseline and 12 week.	12 weeks
Changes of Verbal learning test	Verbal learning test was measured in baseline and 12 week.	12 weeks
Changes of Visual working memory test	Visual working memory test was measured in baseline and 12 week.	12 weeks
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
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
Changes of Brain-derived neurotrophic factor(BDNF)	Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.	12 weeks
Changes of Total antioxidant status(TAS)	Total antioxidant status(TAS) was measured in baseline and 12 week.	12 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Actual): October 8, 2019
• Study Completion (Actual): October 8, 2019

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Cognitive Function; Catechin high contain greentea extract
• Other Study ID Numbers: RNO-CF-EG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No