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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026069
Receipt No. R000029951
Scientific Title Determination of glycemic index (GI) of bread
Date of disclosure of the study information 2017/02/10
Last modified on 2017/08/14

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Basic information
Public title Determination of glycemic index (GI) of bread
Acronym Determination of glycemic index (GI) of bread.
Scientific Title Determination of glycemic index (GI) of bread
Scientific Title:Acronym Determination of glycemic index (GI) of bread.
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Determination of glycemic index (GI) of bread.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glycemic index(GI)
Key secondary outcomes Postprandial blood glucose level,
Postprandial maximum blood glucose level,
Incremental blood glucose area under the curve
GI; Subjects with fasting plasma glucose <100 mg/dL, and =>100 mg/dL, respectively.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 5 days)
bread A
wash out period (at least 5 days)
bread B
Interventions/Control_2 Glucose solution as reference (50g/150ml)
wash out period (at least 5 days)
bread B
wash out period (at least 5 days)
bread A
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
51 years-old >
Gender Male and Female
Key inclusion criteria (1) Aged between 20 and 50 years old at consent.
(2) Fasting plasma glucose 70-126mg/dl
(3) Subjects whose body mass index (BMI) is under 30kg/m2
(4) Subjects who understand the study procedures and agree to participate in the study by giving informed consent prior to the study.
Key exclusion criteria 1) Subjects who have history of malignant diseases.
2) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, organ).
3) Subjects who have previous medical history of drug and/or food allergy.
4) Subjects who have infectious diseases.
5) Subjects who have continuous intake of medicine and/or health food for carbohydrate metabolism
6) Subjects who donated over 200 mL blood within the last one month, and/or over 400 mL blood within the last three month.
7) Subjects with impaired glucose tolerance.
8) Subjects who is menstruating in this clinical test.
9) Females who are pregnant or lactating, and who could become pregnant or lactating during test period.
10) Subjects who plan to participate in other clinical tests.
11) Subjects who are not eligible for this study for some medical reasons.
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhisa Sakano
Organization CPCC Company Limited
Division name Clinical Research Planning Department
Zip code
Address 4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL 03-5297-3112
Email k.s@cpcc.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ichinohe
Organization CPCC Company Limited
Division name Plan Sales Department
Zip code
Address 4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL 03-5297-3112
Homepage URL
Email m.i@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Nisshin Seifun Group Inc.
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
2017 Year 02 Month 10 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
2017 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 09 Day
Last modified on
2017 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029951

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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