UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Postprandial blood glucose level after intake of a bowl of rice topped with beef "Gyudon"
Title of the study (Brief title)	Postprandial blood glucose level after intake of a bowl of rice topped with beef
Region	Japan

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

Objectives
Narrative objectives1	12 subjects who took an anti-aging medical checkup are participated in this study and a blood glucose levels are measured before and 15, 30, 45, 60, 90, and 120 minutes after test diet. The test diet is made combination of rice, vegetables and beef. We have built up a hypothesis that persons with rich skeletal muscles (young muscule age) may be mild in post-prandial hyperglycemia and that the personswith high serum DHEA-s levels (young hormone age) may be mild in the post-prandila hyperglycemia. The purpose of this study is to elucidate this hypothesis.
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 diet
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	5
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Bowl of rice topped with beef is taken.
Interventions/Control_2	Boiled rice + vegetables + beef is taken.
Interventions/Control_3	Boiled rice + beef is taken.
Interventions/Control_4	Boiled rice + vegetables is taken.
Interventions/Control_5	Boiled rice is taken.
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	1)The person who belongs to Doshisha University Faculty of Life and Medical Sciences / Graduate School of Life and Medical Sciences. 2)The person who took an anti-aging medical checkup beforehand.
Key exclusion criteria	The person who has trouble with some chronic malady and has a medicine medical treatment at present.
Target sample size	12

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

Public contact
Name of contact person	Yoshikazu Yonei
Organization	Graduate School of Life and Medical Sciences,Doshisha University
Division name	Aging Medical Research Center
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)

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	2015 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 16 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.toukastress.jp/webj/article/2016/GS16-14.pdf
Results
Other related information

Management information
Registered date	2015 Year 07 Month 28 Day
Last modified on	2017 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021369