UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	(Early morning) Study on blood glucose level and academic performance
Title of the study (Brief title)	(Early morning) Study on blood glucose level and academic performance
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Endocrinology and Metabolism Laboratory medicine Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	According to the National Health and Nutrition Survey of 2009, "Percentage of people who routinely do not eat breakfast" is the highest among males and females in their twenties, the proportion of which is male 21%, women as well 14%. Therefore, in this study, we study the student's breakfast intake situation and blood glucose level.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.casual blood glucose measurement 2.Presence of breakfast intake
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The blood glucose level of the student who is taking breakfast
Interventions/Control_2	Blood glucose level of students who do not take breakfast
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	18 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Nippon Dental University school of life Dentistry at Niigata Student who is fully aware of the purpose and summary of this research and has obtained consent
Key exclusion criteria	Students other than the target age
Target sample size	100

Research contact person
Name of lead principal investigator	Kimito Sano
Organization	The Nippon Dental University school of life Dentistry at Niigata
Division name	Dept of Dent Anesthesiology
Address	1-8 Hamaura-cho,Chuo-ku,Niigata
TEL	025-267-6477
Email	sano@ngt.ndu.ac.jp

Public contact
Name of contact person	Kimito Sano
Organization	The Nippon Dental University school of life Dentistry at Niigata
Division name	Dept of Dent Anesthesiology
Address	1-8 Hamaura-cho,Chuo-ku,Niigata
TEL	025-267-6477
Homepage URL
Email	sano@ngt.ndu.ac.jp

Sponsor
Institute	The Nippon Dental University school of life Dentistry at Niigata
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 12 Month 22 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 21 Day
Anticipated trial start date	2017 Year 11 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 08 Day
Last modified on	2017 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032755