UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on blood glucose level change after intake of food containing modified starch.
Title of the study (Brief title)	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	Masayuki Yagi
Organization	Faculty of Life and Medical Sciences,Doshisha University
Division name	Glycation Stress Research Center
Address	1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL	0774-65-6394
Email	myagi@mail.doshisha.ac.jp

Public contact
Name of contact person	Masayuki Yagi
Organization	Faculty of Life and Medical Sciences,Doshisha University
Division name	Glycation Stress Research Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.toukastress.jp/webj/article/2018/GS18-12.pdf?20181003
Results
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