UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027950 |
|---|---|
| Receipt number | R000032018 |
| Scientific Title | A trial for melatonin effect on postprandial glucose elevation |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/01/28 18:27:12 |
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Basic information
Public title
A trial for melatonin effect on postprandial glucose elevation
Acronym
Melatonin intake study on glucose metabolism
Scientific Title
A trial for melatonin effect on postprandial glucose elevation
Scientific Title:Acronym
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
| 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
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
Anti-Aging Medical Research Center
Zip code
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
Homepage URL
yyonei@mail.doshisha.ac.jp
Sponsor or person
Institute
Graduate School of Life and Medical Sciences,Doshisha University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.toukastress.jp/webj/article/2018/GS18-01.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 | 06 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032018
