UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034289 |
|---|---|
| Receipt number | R000039057 |
| Scientific Title | An investigation on the safety of excessive consumption of coffee |
| Date of disclosure of the study information | 2018/09/27 |
| Last modified on | 2021/06/02 15:25:05 |
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Basic information
Public title
An investigation on the safety of excessive consumption of coffee
Acronym
An investigation on the safety of excessive consumption of coffee
Scientific Title
An investigation on the safety of excessive consumption of coffee
Scientific Title:Acronym
An investigation on the safety of excessive consumption of coffee
Region
| Japan |
Condition
Condition
N/A(People with a BMI of at least 18.5kg/m2 and less than 25kg/m2.)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of continued consumption of coffee three times a day (three times the standard amount of daily consumption) for 4 weeks, using healthy adult male and female subjects.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
<Safety>
-Interview by physician
-Height, body weight and BMI
-Blood pressure and pulse
-Hematological test
-Biochemical test
-Urine analysis
-Adverse events
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Coffee three times a day (three times the standard amount of daily consumption) for 4 weeks
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Adults (men and women) who are at least 20 and under 65 years of age when Informed Consent is taken
2. People with a BMI of at least 18.5 kg/m2 and less than 25 kg/m2
3. People who voluntary give written informed consent to participate in the study before study begins
Key exclusion criteria
1. People who have very irregular dietary habits
2. People on continuous treatment with medication
3. People with medicine or food allergies
4. People using medicine, foods for specified health uses, foods with functional claims, supplements, or diet products that may have an effect on the study
5. People with hypertension , diabetes mellitus, dyslipidemia ,or other lifestyle-related diseases
6. People with gastrointestinal dysfunction, significant liver dysfunction, significant kidney dysfunction, or significant cardiovascular disease
7. People with a history of a gastrectomy/extensive digestive tract excision
8. People with dependence on drugs or alcohol
9. People who are pregnant, nursing, or plan to become pregnant
10. Other people determined to be unsuitable for participation in the study by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Kanamaru |
Organization
Clinic Soigner
Division name
Director
Zip code
270-2231
Address
7-2-18, Minoridai, Matsudo-shi, Chiba, Japan Postal Code: 270-2231
TEL
047-308-3008
key001@inc-cro.co.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Haruna |
Organization
Increase Co., Ltd.
Division name
Clinical Development Department
Zip code
103-0002
Address
1-5-6, Nihonbashi Bakuro-cho, Chuo-ku, Tokyo Imasu Office Bakurocho Bldg 8F Postal Code: 103-0002
TEL
03-6231-1394
Homepage URL
key001@inc-cro.co.jp
Sponsor or person
Institute
Yutaka Kanamaru
Institute
Department
Personal name
Funding Source
Organization
Key Coffee Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
AGEO Medical Clinic
Address
3133 Haraichi Ageo, Saitama
Tel
048-720-2730
unknown
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
| 2018 | Year | 09 | Month | 27 | 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
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
| 2018 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 27 | Day |
Last modified on
| 2021 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039057
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
