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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03826017
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Young Chul Chung, Chonbuk National University Hospital

Tracking Information
First Submitted Date  ICMJE January 30, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date February 4, 2019
Estimated Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Changes of Visual learning test [ Time Frame: 12 weeks ]
    Visual learning test was measured in baseline and 12 week.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Changes of Visual learning test [ Time Frame: 12 weeks ]
    Visual learning test was measured in baseline and 12 week.
  • Changes of MoCA-K [ Time Frame: 12 weeks ]
    MoCA-K was measured in baseline and 12 week.
Change History Complete list of historical versions of study NCT03826017 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Changes of Auditory continuous performance test [ Time Frame: 12 weeks ]
    Auditory continuous performance test was measured in baseline and 12 week.
  • Changes of Verbal learning test [ Time Frame: 12 weeks ]
    Verbal learning test was measured in baseline and 12 week.
  • Changes of Visual working memory test [ Time Frame: 12 weeks ]
    Visual working memory test was measured in baseline and 12 week.
  • 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).
  • 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.
  • 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.
  • Changes of Total antioxidant status(TAS) [ Time Frame: 12 weeks ]
    Total antioxidant status(TAS) was measured in baseline and 12 week.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Changes of Auditory continuous performance test [ Time Frame: 12 weeks ]
    Auditory continuous performance test was measured in baseline and 12 week.
  • Changes of Verbal learning test [ Time Frame: 12 weeks ]
    Verbal learning test was measured in baseline and 12 week.
  • Changes of Visual working memory test [ Time Frame: 12 weeks ]
    Visual working memory test was measured in baseline and 12 week.
  • Changes of Perceived stress scale(PSS) [ Time Frame: 12 weeks ]
    Perceived stress scale(PSS) was measured in baseline and 12 week.
  • Changes of Beck Depression Inventory(BDI) [ Time Frame: 12 weeks ]
    Beck Depression Inventory(BDI) was measured in baseline and 12 week.
  • Changes of Brain-derived neurotrophic factor(BDNF) [ Time Frame: 12 weeks ]
    Brain-derived neurotrophic factor(BDNF) was measured in baseline and 12 week.
  • Changes of Total antioxidant status(TAS) [ Time Frame: 12 weeks ]
    Total antioxidant status(TAS) was measured in baseline and 12 week.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Catechin High Contain Greentea Extract on Improvement of Cognitive Function
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Cognitive Function
Intervention  ICMJE
  • Dietary Supplement: Catechin high contain greentea extract
    Catechin high contain greentea extract 260 mg/day for 12 weeks.
  • Dietary Supplement: Placebo
    Placebo for 12 weeks.
Study Arms  ICMJE
  • Experimental: Catechin high contain greentea extract
    Catechin high contain greentea extract for 260 mg/day 12 weeks.
    Intervention: Dietary Supplement: Catechin high contain greentea extract
  • Placebo Comparator: Placebo
    Placebo for 12 weeks.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2020
Estimated Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Young-chul Chung, MD 82 63 250 2185 chungyc@jbnu.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03826017
Other Study ID Numbers  ICMJE RNO-CF-EG
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Young Chul Chung, Chonbuk National University Hospital
Study Sponsor  ICMJE Chonbuk National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Young-chul Chung, MD Chonbuk National University Hospital
PRS Account Chonbuk National University Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP