UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048584 |
|---|---|
| Receipt number | R000047992 |
| Scientific Title | Examination of clinical effect of green coffee bean extract on healthy subjects. |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2022/08/04 13:08:55 |
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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
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
hisajima@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047992
