UMIN-CTR Clinical Trial

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

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Teikyo Heisei University

Institute

Department

Personal name

Organization

Vidya Japan K.K.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Teikyo Heisei University

Address

2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo

Tel

03-5843-4860

Email

hisajima@thu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

08

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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