UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043868