UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A trial for melatonin effect on postprandial glucose elevation
Title of the study (Brief title)	Melatonin intake study on glucose metabolism
Region	Japan

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

Objectives
Narrative objectives1	It was indicated that exogenous melatonin may reduce the maximum value of blood glucose in the previous animal study which was supported by JSPS KAKENHI Grant Number 26350917:"Does melatonin control the production of AGEs and RAGE?".The purpose of this study to elucidate whether or not the same phenomenon can be observed.
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	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Boiled rice 200g + Melatonin 2mg
Interventions/Control_2	Boiled rice 200g
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	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	15

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	Anti-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	Graduate School of Life and Medical Sciences,Doshisha University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 15 Day
Anticipated trial start date	2017 Year 07 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/2018/GS18-01.pdf
Results
Other related information

Management information
Registered date	2017 Year 06 Month 27 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032018