UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037674
Receipt number R000042966
Scientific Title An observational study for blood glucose and lifestyle/habits SBF-2019-04
Date of disclosure of the study information 2019/08/16
Last modified on 2021/10/27 15:50:30

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Basic information

Public title

An observational study for blood glucose and lifestyle/habits
SBF-2019-04

Acronym

An observational study for blood glucose and lifestyle/habits

Scientific Title

An observational study for blood glucose and lifestyle/habits
SBF-2019-04

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

-

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

1000


Research contact person

Name of lead principal investigator

1st name Takanori
Middle name
Last name Teramoto

Organization

Suntory Beverage & Food Limited

Division name

Development and Design Department

Zip code

211-0067

Address

13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, Japan

TEL

050-3182-6114

Email

Takanori_Teramoto@suntory.co.jp


Public contact

Name of contact person

1st name Hiroyuki
Middle name
Last name Kato

Organization

Suntory Beverage & Food Limited

Division name

Development and Design Department

Zip code

211-0067

Address

13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, Japan

TEL

050-3182-6139

Homepage URL


Email

Hiroyuki_Kato@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

Ethics Committees of Nihonbashi Egawa Clinic

Address

Kotobuki Building.2F, 1-1-3, Yaesu, Chuo-ku, Tokyo, Japan

Tel

03-5204-0311

Email

jim@medipharma.co.jp


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 08 Month 16 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

2019 Year 08 Month 09 Day

Date of IRB

2019 Year 08 Month 09 Day

Anticipated trial start date

2019 Year 08 Month 16 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

-


Management information

Registered date

2019 Year 08 Month 13 Day

Last modified on

2021 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042966


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name