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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023814
Receipt No. R000026814
Scientific Title Postprandial blood glucose level after intake of food and breakfast
Date of disclosure of the study information 2016/08/30
Last modified on 2017/08/09

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Basic information
Public title Postprandial blood glucose level after intake of food and breakfast
Acronym Postprandial blood glucose level after intake of food and breakfast
Scientific Title Postprandial blood glucose level after intake of food and breakfast
Scientific Title:Acronym Postprandial blood glucose level after intake of food and breakfast
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A fluctuation of a blood glucose level after meal by a bowl of rice topped with beef and the breakfast bought at a convenience store is compared and analyzed, and makes it clear what kind of influence to have in a point as accumulation of glycative stress.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a blood-glucose level of before and 15, 30, 45, 60, 90, and 120 minutes after test food
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 10
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Boiled rice 200g
Interventions/Control_2 Breakfast:Bowl of rice topped with beef
Lunch:Boiled rice 200g
Interventions/Control_3 Breakfast:The meal bought at a convenience store
Lunch:Boiled rice 200g
Interventions/Control_4 Breakfast:Don't have a meal
Lunch:Boiled rice 200g
Interventions/Control_5 Breakfast:Boiled rice 200g
Lunch:Boiled rice 200g
Interventions/Control_6 Bowl of rice of 150g topped with beef
Interventions/Control_7 Bowl of rice of 180g topped with beef
Interventions/Control_8 Bowl of rice of 200g topped with beef
Interventions/Control_9 Bowl of rice of 250g topped with beef
Interventions/Control_10 Bowl of rice of 300g topped with beef

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria The person who belongs to Doshisha University Faculty of Life and Medical Sciences / Graduate School of Life and Medical Sciences.
Key exclusion criteria The person who has trouble with some chronic malady and has a medicine medical treatment at present.
Target sample size 13

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Yonei
Organization Graduate School of Life and Medical Sciences,Doshisha University
Division name Anti-Aging Medical Research Center
Zip code
Address 1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL 0774-65-6394
Email yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshikazu Yonei
Organization Graduate School of Life and Medical Sciences,Doshisha University
Division name Aging Medical Research Center
Zip code
Address 1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL 0774-65-6394
Homepage URL
Email yyonei@mail.doshisha.ac.jp

Sponsor
Institute Anti-Aging Medical Research Center,Graduate School of Life and Medical Sciences,Doshisha University
Institute
Department

Funding Source
Organization YOSHINOYA HOLDINGS CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.toukastress.jp/webj/article/2017/GS17-10.pdf
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
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2017 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026814

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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