UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038506 |
|---|---|
| Receipt number | R000043868 |
| Scientific Title | An observational study for blood glucose and lifestyle/habits SBF-2019-05 |
| Date of disclosure of the study information | 2019/11/07 |
| Last modified on | 2020/11/09 18:37:46 |
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Basic information
Public title
An observational study for blood glucose and lifestyle/habits
SBF-2019-05
Acronym
An observational study for blood glucose and lifestyle/habits
Scientific Title
An observational study for blood glucose and lifestyle/habits
SBF-2019-05
Scientific Title:Acronym
An observational study for blood glucose and lifestyle/habits
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate blood glucose and lifestyle/habits.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose
Lifestyle/habits
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Healthy male and female whose age are 20 <= years old <65.
(2)Subjects who are able to submit the written informed consents.
Key exclusion criteria
(1)Females in pregnancy, lactation and scheduled pregnancy period.
(2)Subjects who are attending specified studies or attended specified studies within past 4 weeks.
(3)With present heart disorder, liver disorder, or kidney disorder
(4)With previous or present cardiac disorder
(5)With diabetes mellitus, or
(6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Minami |
Organization
Suntory Beverage & Food Limited
Division name
Development and Design Department
Zip code
211-0067
Address
13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL
050-3182-6161
Hisako_Nakamura@suntory.co.jp
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Onozato |
Organization
Suntory Beverage & Food Limited
Division name
Development and Design Department
Zip code
211-0067
Address
13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan
TEL
050-3182-6116
Homepage URL
Misaki_Onozato@suntory.co.jp
Sponsor or person
Institute
Suntory Beverage & Food Limited
Institute
Department
Personal name
Funding Source
Organization
Suntory Beverage & Food Limited
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
Suntory holdings limited
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
Tel
0774-66-1110
None
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
| 2019 | Year | 11 | Month | 07 | 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
93
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
| 2019 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2019 | Year | 11 | Month | 06 | Day |
Last modified on
| 2020 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043868
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
