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

NCT03826017 | Completed

• 1 other identifier: RNO-CF-EG
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Function

Keywords

Catechin high contain greentea extract; Cognitive Function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Changes of Auditory continuous performance test

  12 weeks

• Changes of Verbal learning test

  12 weeks

• Changes of Visual working memory test

  12 weeks

• Changes of Perceived stress scale(PSS)

  12 weeks

• Changes of Beck Depression Inventory(BDI)

  12 weeks

Study Arms (2)

Catechin high contain greentea extract

EXPERIMENTAL

Catechin high contain greentea extract for 260 mg/day 12 weeks.

Dietary Supplement: Catechin high contain greentea extract

Placebo

PLACEBO COMPARATOR

Placebo for 12 weeks.

Dietary Supplement: Placebo

Interventions

Catechin high contain greentea extract DIETARY_SUPPLEMENT

Catechin high contain greentea extract 260 mg/day for 12 weeks.

Catechin high contain greentea extract

Placebo DIETARY_SUPPLEMENT

Placebo for 12 weeks.

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Study Officials

• Young-chul Chung, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 1, 2019
• Study Start: December 5, 2018
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

KR (1)