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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038670
Receipt No. R000044074
Scientific Title Exploratory single center standard diet comparison open-label Randomized Crossover trial for the effects of Mochi-Rice for endocrine after meals.
Date of disclosure of the study information 2020/01/01
Last modified on 2020/11/02

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Basic information
Public title The effects of Mochi-Rice for endocrine after meals.
Acronym The effects of Mochi-Rice for endocrine after meals.
Scientific Title Exploratory single center standard diet comparison open-label Randomized Crossover trial for the effects of Mochi-Rice for endocrine after meals.
Scientific Title:Acronym Exploratory single center standard diet comparison open-label Randomized Crossover trial for the effects of Mochi-Rice for endocrine after meals.
Region
Japan

Condition
Condition Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of Mochi-Rice for endocrine after meals.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose, CPR, glucagon, GIP, GLP-1
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 To eat standard diet
Interventions/Control_2 To eat Mochi rice diet.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Healthy volunteer
Key exclusion criteria None
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Michiaki
Middle name
Last name Fukui
Organization Kyoto Prefectural University of Medicine
Division name Department of Endocrinology and Metabolism
Zip code 6028566
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL +81-75-251-5505
Email michiaki@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Masahide
Middle name
Last name Hamaguchi
Organization Kyoto Prefectural University of Medicine
Division name Department of Endocrinology and Metabolism
Zip code 6028566
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL +81-75-251-5505
Homepage URL
Email mhama@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization 4 universities cooperation study support projects (public offering type)
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee, Kyoto Prefectural University of Medicine
Address Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566
Tel 075-251-5337
Email rinri@koto.kpu-m.ac.jp

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
2020 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
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 No longer recruiting
Date of protocol fixation
2019 Year 12 Month 31 Day
Date of IRB
2020 Year 02 Month 13 Day
Anticipated trial start date
2020 Year 02 Month 13 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 24 Day
Last modified on
2020 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044074

Research Plan
Registered date File name
2020/11/02 研究計画書モチ米v9.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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