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Completed

NCT Number: NCT03826017

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

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Key information

Conditions

Cognitive Function

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catechin high contain greentea extract

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo for 12 weeks.

Primary outcomes

  1. Changes of Visual learning test

    Time frame: 12 weeks

    Visual learning test was measured in baseline and 12 week.

  2. Changes of Korean Version of the Montreal Cognitive Assessment(MoCA-K)

    Time frame: 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.

Secondary outcomes

  1. Changes of Auditory continuous performance test

    Time frame: 12 weeks

    Auditory continuous performance test was measured in baseline and 12 week.

  2. Changes of Verbal learning test

    Time frame: 12 weeks

    Verbal learning test was measured in baseline and 12 week.

  3. Changes of Visual working memory test

    Time frame: 12 weeks

    Visual working memory test was measured in baseline and 12 week.

  4. Changes of Perceived stress scale(PSS)

    Time frame: 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).

  5. Changes of Beck Depression Inventory(BDI)

    Time frame: 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.

  6. Changes of Brain-derived neurotrophic factor(BDNF)

    Time frame: 12 weeks

    Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.

  7. Changes of Total antioxidant status(TAS)

    Time frame: 12 weeks

    Total antioxidant status(TAS) was measured in baseline and 12 week.

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 1, 2019
Registry last updated
Jul 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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