UMIN-CTR Clinical Trial

Basic information
Public title	Examination of clinical effect of green coffee bean extract on healthy subjects.
Acronym	Examination of clinical effect of green coffee bean extract on healthy subjects.
Scientific Title	Examination of clinical effect of green coffee bean extract on healthy subjects.
Scientific Title:Acronym	Examination of clinical effect of green coffee bean extract on healthy subjects.
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examines the effect of ingestion of green coffee bean extract on healthy subjects on brain functions such as memory, concentration and attention, and their biomarkers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Praimary outcomes is Bourdon' seher Durchstreichte. A Bourdon' seher Durchstreichte is performed before the experiment and after 4 weeks, 8 weeks, and 12 weeks.
Key secondary outcomes	1.Mini Mental State Examination-Japanese 2.WHOQOL26 3.Uchida Kleperin test 4.Cerebral blood flow in Uchida Kleperin 5.Blood BDNF 6.Blood alpha-synuclein 7.Blood eicosanoyl-5-hydroxytryptamide 8.Blood chlorogenic acid 9.Red blood cells, Hb, hematocrit, platelets, average red blood cell volume, Mean corpuscular hemoglobin Hb amount, mean red blood cell Hb concentration, reticulocyte, white blood cell)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Investigational Product (IP): Neurocaf (Standardized green coffee bean extract), 350 mg capsules
Interventions/Control_2	Placebo: Maltodextrin, 350 mg capsules
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Men and women between the ages of 50 and 65. 2. Healthy individuals with a Mini-Mental State Examination (MMSE) score of 24 or higher (because a MMSE score of 23 or lower may be dementia). 3. Those who score 4 points or more on the Simple Fatigue Scale (4-7 points are moderate and 8-10 points are severe). 4. Those who are judged to be right-handed by the H.N. dominant hand test. Unification of the dominant hand is a necessary condition for measuring the amount of hemoglobin (Hb) in the cerebrovascular by NIRS. 5. Those who have subjective symptoms of decreased memory, concentration, and attention (recently feel these symptoms compared to before) or have been pointed out by close relatives that they have decreased memory, concentration, and attention. Person. 6. Those who can attend the research site within the research period. 7. Those who have written consent to participate in this study. 8. Those who have not participated in other experiments within 3 months.
Key exclusion criteria	1. Those who are currently receiving medication due to some kind of breath. 2. Those who currently have a habit of taking or applying drugs. 3. Persons with a history of mental illness or current medical history. 4. Treatment for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, cerebral contusion Head trauma Those who have experience of hospitalization surgery. 5. Persons with a history of hypertension, dyslipidemia, diabetes, or current medical history. 6. Persons with a history or current medical history of heart failure, renal failure, hepatitis B, hepatitis C. 7. Persons with a history or current medical history of serious disorders such as liver, kidney, heart, lungs, and blood. 8. As a general rule, those who have a history of comorbidities in the digestive system. 9. Persons with a BMI (kg / m2) of 30 or more. 10. Those who drink more than 60g / day on average in terms of alcohol per day. 11. Those who smoke an average of 21 or more cigarettes per day. 12. Those with severe anemia. 13. Those who may have allergic symptoms to the test product, or those who may have serious allergic symptoms to other foods and medicines. 14. Currently, and within the past 3 months, those who have a habit of continuing to take functional foods, health foods, and supplements that appeal to similar effects to the test product, and who plan to take them during the study period. Person. 15. Those who have a habit of continuing to take health foods and supplements containing test-containing ingredients, and who plan to take them during the test period, now and within the past 3 months. 16. Those who may change their lifestyle during the examination period. 17. Those who are currently participating in other human clinical trials, or those who have not been heard for 3 months after participating in other human clinical trials. 18. Others who are judged by the investigator to be inappropriate for this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Hisajima
Organization	Teikyo Heisei University
Division name	Department of Acupuncture and Moxibustion, Faculty of Health Care
Zip code	170-8445
Address	2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo
TEL	03-5843-4860
Email	hisajima@thu.ac.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Hisajima
Organization	Teikyo Heisei University
Division name	Department of Acupuncture and Moxibustion, Faculty of Health Care
Zip code	170-8445
Address	2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo
TEL	03-5843-4860
Homepage URL
Email	hisajima@thu.ac.jp

Sponsor
Institute	Teikyo Heisei University
Institute
Department

Funding Source
Organization	Vidya Japan K.K.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Teikyo Heisei University
Address	2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo
Tel	03-5843-4860
Email	hisajima@thu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 08 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	63
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 08 Month 21 Day
Date of IRB	2020 Year 08 Month 30 Day
Anticipated trial start date	2020 Year 09 Month 24 Day
Last follow-up date	2021 Year 09 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 08 Month 04 Day
Last modified on	2022 Year 08 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047992

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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