UMIN-CTR Clinical Trial

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

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

a blood-glucose level of before and 15, 30, 45, 60, 90, and 120 minutes after test food

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Sanwa Starch Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2017

Year

09

Month

06

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=R000032931