UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032906
Receipt No. R000037515
Scientific Title Measurement study on Glycemic index of amazake made from rice malt
Date of disclosure of the study information 2019/06/01
Last modified on 2018/07/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Measurement study on Glycemic index of amazake made from rice malt
Acronym Measurement study on Glycemic index of amazake made from rice malt
Scientific Title Measurement study on Glycemic index of amazake made from rice malt
Scientific Title:Acronym Measurement study on Glycemic index of amazake made from rice malt
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measurement of glycemic index (GI) of amazake made from rice malt
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glycemic Index (GI)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 TRELAN-G50, blood samples drawn at 15, 30, 45, 60, 90, 120 min after consumption - wash out period (more than 1 day), rice-malt amazake
300ml, blood samples drawn at 15, 30, 45, 60, 90, 120 min after consumption - wash out period (more than 1 day) - rice-malt amazake 300ml, blood samples drawn at 15, 30, 45, 60, 90, 120 min after consumption
Interventions/Control_2
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
50 years-old >=
Gender Male and Female
Key inclusion criteria 1.Persons whose fasting plasma glucose 70-110mg/dl
2.Persons whose body mass weight is 30 or less.
3.Persons who do not have impaired glucose tolerance in the past one year examination.
4.Persons who are not taking drugs such as antihypertensive agents.
5.Persons who received sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, agreed to participate with a written document.
Key exclusion criteria 1.Persons who have diabetes.
2.Persons who are pregnant or breastfeeding.
3.Persons who are allergic to the test food.
4.Persons who are judged as inappropriate for subjects by chief investigator.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mariko Uehara
Organization Tokyo University of Agriculture
Division name Faculty of Applied Bioscience
Zip code
Address 1-1-1, Sakuragaoka, Setagaya-city, Tokyo
TEL 03-5477-2252
Email mari@nodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Takahashi
Organization Tokyo University of Agriculture
Division name Faculty of Applied Bioscience
Zip code
Address 1-1-1, Sakuragaoka, Setagaya-city, Tokyo
TEL 03-5477-2584
Homepage URL
Email nt204885@nodai.ac.jp

Sponsor
Institute Tokyo University of Agriculture
Faculty of Applied Bioscience
Institute
Department

Funding Source
Organization Marukome Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Marukome Co.,Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 06 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
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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 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
2018 Year 06 Month 07 Day
Last modified on
2018 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037515

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.