UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018678
Receipt number R000021620
Scientific Title Measurement of glycemic index (GI) of whole wheat bread: randomized, placebo-controlled, Single blind cross-over trial.
Date of disclosure of the study information 2015/08/20
Last modified on 2016/02/17 15:12:00

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Basic information

Public title

Measurement of glycemic index (GI) of whole wheat bread: randomized, placebo-controlled, Single blind cross-over trial.

Acronym

Measurement of glycemic index (GI) of whole wheat bread.

Scientific Title

Measurement of glycemic index (GI) of whole wheat bread: randomized, placebo-controlled, Single blind cross-over trial.

Scientific Title:Acronym

Measurement of glycemic index (GI) of whole wheat bread.

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Measurement of glycemic index (GI) of whole wheat bread.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glycemic index(GI)
Measurement of GI on a day when test foods were eaten.

Key secondary outcomes

Postprandial blood glucose level,
Postprandial maximum blood glucose level,
Incremental blood glucose area under the curve


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Glucose solution as reference (50g/150ml) - wash out period (at least 1 week) - whole wheat bread - wash out period (at least 1 week) - wheat flour bread

Interventions/Control_2

Glucose solution as reference (50g/150ml) - wash out period (at least 1 week) - wheat flour bread - wash out period (at least 1 week) - whole wheat bread

Interventions/Control_3


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) Age between 20 and 59 years old at consent.
(2) Fasting plasma glucose 70 - 125mg/dl
(3) Subjects understand the study procedures and agree to participate in the study by giving informed consent, which is accordance with the Declaration of Helsinki, prior to the study.

Key exclusion criteria

(1) Subjects who take diabetes drug.
(2) Subjects who have insulin treatment.
(3) Subjects who have wheat or milk or egg allergy.
(4) Subjects who have history of surgery in gastrointestinal tract.
(5) Females who are pregnant or lactating, and who could become pregnant or lactating during test period.
(6) Subjects who have continuous intake of dietary fiber supplement or whole grain.
(7) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiichiro Aoe

Organization

Otsuma Women's University

Division name

Faculty of Home Economics

Zip code


Address

12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan

TEL

03-5275-6048

Email

s-aoe@otsuma.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seiichiro Aoe

Organization

Otsuma Women's University

Division name

Faculty of Home Economics

Zip code


Address

12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan

TEL

03-5275-6048

Homepage URL


Email

s-aoe@otsuma.ac.jp


Sponsor or person

Institute

Faculty of Home Economics, Otsuma Women's University

Institute

Department

Personal name



Funding Source

Organization

Research Project on Development of Agricultural Products and Foods with Health-promoting benefits

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Nisshin Seifun Group Inc.

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

2015 Year 08 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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

2015 Year 07 Month 28 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 21 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

2015 Year 08 Month 14 Day

Last modified on

2016 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021620


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name