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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038506
Receipt No. 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 2019/11/06

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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
Email 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
Email Misaki_Onozato@suntory.co.jp

Sponsor
Institute Suntory Beverage & Food Limited
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 07 Day
Date of IRB
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
2019 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.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


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