UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034009
Receipt number R000038748
Scientific Title Study on the influence on sugar metabolism by food intake.
Date of disclosure of the study information 2018/09/05
Last modified on 2021/05/25 16:54:31

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Basic information

Public title

Study on the influence on sugar metabolism by food intake.

Acronym

Study on the influence on sugar metabolism by food intake.

Scientific Title

Study on the influence on sugar metabolism by food intake.

Scientific Title:Acronym

Study on the influence on sugar metabolism by food intake.

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Previous studies have reported that proteins, lipids, vinegar (acetic acid) and dietary fiber contained in foods have an effect of alleviating an increase in postprandial blood glucose level when cooked with carbohydrates.
The purpose of this study is to examine how the amount of each nutrient component affects the change in blood glucose level after meals by changing the amount of food serving as an indicator of these nutritional ingredients and ingesting them. By using the results of the verification, we obtain information to estimate the influence on the postprandial blood glucose level when combined foods containing various nutrients are cooked with carbohydrates.

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

10

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Take 200 g of white rice in 5 minutes.

Interventions/Control_2

Take 200 g of white rice and 50 g of steamed chicken in 10 minutes.

Interventions/Control_3

Take 200 g of white rice and 110 g of stemade chicken in 10 minutes.

Interventions/Control_4

Take 200 g of white rice and 14 g of olive oil in 10 minutes.

Interventions/Control_5

Take 200 g of white rice and 28 g of olive oil in 10 minutes.

Interventions/Control_6

Take 200 g of white rice and 15 g of grain vinegar in 10 minutes.

Interventions/Control_7

Take 200 g of white rice and 30 g of grain vinegar in 10 minutes.

Interventions/Control_8

Take 200 g of white rice and 5.2 g of indigestible dextrin in 10 minutes.

Interventions/Control_9

Take 200 g of white rice and 10.4 g of indigestible dextrin in 10 minutes.

Interventions/Control_10

Take 200 g of white rice and 50 g of cabbage in 10 minutes.


Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

30 years-old >

Gender

Male and Female

Key inclusion criteria

[1]Aged between 20 and 29
[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 400 mL 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]Individuals who is pregnant or lactate
[11]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements 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

17


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Yagi

Organization

Faculty of Life and Medical Sciences, Doshisha University

Division name

Glycative Stress Research Center

Zip code

610-0394

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 Masayuki
Middle name
Last name Yagi

Organization

Faculty of Life and Medical Sciences, Doshisha University

Division name

Glycative Stress Research Center

Zip code

610-0394

Address

1-3 Tatara Miyakodani,Kyotanabe City, Kyoto

TEL

0774-65-6394

Homepage URL


Email

myagi@mail.doshisha.ac.jp


Sponsor or person

Institute

Doshisha University

Institute

Department

Personal name



Funding Source

Organization

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

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Japanese Council for Science, Technology and Innovation (CSTI), Cross-ministerial Strategic Innovation Promotion Program


IRB Contact (For public release)

Organization

Doshisha University

Address

Higashiiru Karasuma-dori Imadegawa Kamigyo-ku Kyoto

Tel

075-251-3158

Email

ji-rinri@mail.doshisha.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

2018 Year 09 Month 05 Day


Related information

URL releasing protocol

https://www.toukastress.jp/webj/article/2020/GS20-32.pdf

Publication of results

Published


Result

URL related to results and publications

https://www.toukastress.jp/webj/article/2020/GS20-25.pdf

Number of participants that the trial has enrolled

20

Results

When the model foods A,B,C and E were ingested in high doses(H), the iAUC tended to be lower than that of the standard food. In particular,Delta Cmax and iAUC in test foodC were significantly decreased (p<0.05) and the effect was in a dose dependent manner. On the other hand, the model foodD did not have a suppressing effect on PPHG. As compared to the standard food, the complex foodF tended to lower Delta Cmax and iAUC, while the complex foodsG,H,and I significantly reduced Delta Cmax and iAUC (p<0.05).

Results date posted

2021 Year 05 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The subjects were 20 healthy young men and women(8men,12women,23.3+-1.8years).

Participant flow

There were 20 subjects who met the following selection criteria. Men and women between the ages of 20 and 29 at the time of obtaining consent to participate in the study. Study participants were healthy persons without chronic illness.

Adverse events

None.

Outcome measures

AUC,Cmax

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 08 Month 31 Day

Date of IRB

2018 Year 08 Month 27 Day

Anticipated trial start date

2018 Year 09 Month 10 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

[Interventions/Control_11]Take 200 g of white rice and 100 g of cabbage in 10 minutes
[Interventions/Control_12]Take 200 g of white rice, 150 g of dumpling, 15 g of ponzu sauce in 10 minutes.


Management information

Registered date

2018 Year 09 Month 03 Day

Last modified on

2021 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038748


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name