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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018678
Receipt No. 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

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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
Institute Faculty of Home Economics, Otsuma Women's University
Institute
Department

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
URL(English) https://upload.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


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