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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029026
Receipt No. R000032931
Scientific Title Study on blood glucose level change after intake of food containing modified starch.
Date of disclosure of the study information 2017/10/01
Last modified on 2019/01/28

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Basic information
Public title Study on blood glucose level change after intake of food containing modified starch.
Acronym Study on blood glucose level change after intake of food containing modified starch.
Scientific Title Study on blood glucose level change after intake of food containing modified starch.
Scientific Title:Acronym Study on blood glucose level change after intake of food containing modified starch.
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to conduct a human test on changes in blood glucose level after intake of food containing modified starch and evaluate the results and verify whether foods containing modified starch reduce weight of glycation stress.
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 Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The modified starch A ingesting bread blended with 50% replacement of the wheat flour
Interventions/Control_2 The modified starch B ingesting bread blended with 50% replacement of the wheat flour
Interventions/Control_3 The modified starch C ingesting bread blended with 50% replacement of the wheat flour
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
60 years-old >
Gender Male and Female
Key inclusion criteria [1]Aged between 20 and 59
[2]Individuals who are healthy and do not treat any disease
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can have an examination on a designated check day
[5]Individuals judged appropriate for the study by the principal
Key exclusion criteria [1]Individuals using medical products
[2]Individuals who are or are under treatment or have a history of Impaired Glucose Tolerance,mental disabilities,sleep disorder,hypertension,diabetes,fat metabolism or the other serious dysfunctions
[3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it.) [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease
[5]Individual who have digestive organ disease(disease of an appendix is removed)
[6]Individuals whose BMI is over 30 kg/m2
[7]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[8]Individuals with serious anemia
[9]Individuals who are sensitive to test products or Individual with fear who causes severe allergy in a food and medical supplies
[10]Individual who is pregnant or lactate
[11]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments of glycometabolism in the past 3 month or will ingest those foods during the test period
[12]Individuals judged inappropriate for the study by the principal
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Yagi
Organization Faculty of Life and Medical Sciences,Doshisha University
Division name Glycation Stress Research Center
Zip code
Address 1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL 0774-65-6394
Email myagi@mail.doshisha.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Yagi
Organization Faculty of Life and Medical Sciences,Doshisha University
Division name Glycation Stress Research Center
Zip code
Address 1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL 0774-65-6394
Homepage URL
Email myagi@mail.doshisha.ac.jp

Sponsor
Institute Glycation Stress Research Center,Faculty of Life and Medical Sciences,Doshisha University
Institute
Department

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

Other related organizations
Co-sponsor
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
2017 Year 10 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/GS18-12.pdf?20181003
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
2017 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 10 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 09 Month 06 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=R000032931

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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