UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023814
Receipt number R000026814
Scientific Title Postprandial blood glucose level after intake of food and breakfast
Date of disclosure of the study information 2016/08/30
Last modified on 2017/08/09 17:01:17

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Basic information

Public title

Postprandial blood glucose level after intake of food and breakfast

Acronym

Postprandial blood glucose level after intake of food and breakfast

Scientific Title

Postprandial blood glucose level after intake of food and breakfast

Scientific Title:Acronym

Postprandial blood glucose level after intake of food and breakfast

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A fluctuation of a blood glucose level after meal by a bowl of rice topped with beef and the breakfast bought at a convenience store is compared and analyzed, and makes it clear what kind of influence to have in a point as accumulation of glycative 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

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

10

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Boiled rice 200g

Interventions/Control_2

Breakfast:Bowl of rice topped with beef
Lunch:Boiled rice 200g

Interventions/Control_3

Breakfast:The meal bought at a convenience store
Lunch:Boiled rice 200g

Interventions/Control_4

Breakfast:Don't have a meal
Lunch:Boiled rice 200g

Interventions/Control_5

Breakfast:Boiled rice 200g
Lunch:Boiled rice 200g

Interventions/Control_6

Bowl of rice of 150g topped with beef

Interventions/Control_7

Bowl of rice of 180g topped with beef

Interventions/Control_8

Bowl of rice of 200g topped with beef

Interventions/Control_9

Bowl of rice of 250g topped with beef

Interventions/Control_10

Bowl of rice of 300g topped with beef


Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

The person who belongs to Doshisha University Faculty of Life and Medical Sciences / Graduate School of Life and Medical Sciences.

Key exclusion criteria

The person who has trouble with some chronic malady and has a medicine medical treatment at present.

Target sample size

13


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshikazu Yonei

Organization

Graduate School of Life and Medical Sciences,Doshisha University

Division name

Anti-Aging Medical Research Center

Zip code


Address

1-3 Tatara Miyakodani,Kyotanabe City,Kyoto

TEL

0774-65-6394

Email

yyonei@mail.doshisha.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshikazu Yonei

Organization

Graduate School of Life and Medical Sciences,Doshisha University

Division name

Aging Medical Research Center

Zip code


Address

1-3 Tatara Miyakodani,Kyotanabe City,Kyoto

TEL

0774-65-6394

Homepage URL


Email

yyonei@mail.doshisha.ac.jp


Sponsor or person

Institute

Anti-Aging Medical Research Center,Graduate School of Life and Medical Sciences,Doshisha University

Institute

Department

Personal name



Funding Source

Organization

YOSHINOYA HOLDINGS 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

2016 Year 08 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.toukastress.jp/webj/article/2017/GS17-10.pdf

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

2016 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 15 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

2016 Year 08 Month 29 Day

Last modified on

2017 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026814


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name