UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026069 |
|---|---|
| Receipt number | 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 13:57:37 |
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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
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
m.i@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029951
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
