UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030186 |
|---|---|
| Receipt number | R000034478 |
| Scientific Title | Examination on a transition in a post-meal blood sugar level by three dietary methods(examination on soy first effects) |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2018/03/01 08:35:05 |
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Basic information
Public title
Examination on a transition in a post-meal blood sugar level by three dietary methods(examination on soy first effects)
Acronym
Examination on a transition in a post-meal blood sugar level by three dietary methods(examination on soy first effects)
Scientific Title
Examination on a transition in a post-meal blood sugar level by three dietary methods(examination on soy first effects)
Scientific Title:Acronym
Examination on a transition in a post-meal blood sugar level by three dietary methods(examination on soy first effects)
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine transitions in the post-meal blood sugar level among healthy males and females aged 30 and over, below 50 by three dietary methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Post-meal blood sugar level
2)Survey on fullness
3)AUC (Area Under Curve)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
On the day intake of the two of warmed rice balls within 8 minutes.
Interventions/Control_2
On the day intake of the two of warmed rice balls after finished eating the salad within 13 minutes.
Interventions/Control_3
On the day intake of the two of warmed rice balls after finished eating the boiled soybeans within 13 minutes.
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Age:30 and over, below 50.
2)Sex:Males and females with Japanese nationality.
3)BMI of 22 and over, below 25.
4)Consumption of carbohydrates in three meals a day.
Key exclusion criteria
1)Currently in treatment with medication, or currently in exercise therapy and/or dietary therapy under medical supervision.
2)Previous history of hepatic disorder, severe kidney, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disorder, or a complication of these.
3)Arrhythmia or serious anemia.
4)Use of a coagulant.
5)Symptoms of dizziness, lightheadedness, palpitation, headache, breathlessness, etc.
6)Presence or previous history of hepatitis.
7)Current intake of a health food product or a supplement that has an influence on the blood sugar level.
8)Pregnant or nursing.
9)Presence or previous history of mental disorder (depression, etc.).
10)Presence or previous history of allergic reaction to medication or a food product.
11)Working on night shift or with alternative work schedule.
12)Participation in any other clinical study involving human subjects within 3 months or current participation in any other clinical study involving human subjects.
13)Subjects who are deemed to be unsuitable by the investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
ochitani@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ochitani Daisuke |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
ochitani@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Integrate 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
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 | 12 | Month | 01 | 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 | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | 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
| 2017 | Year | 11 | Month | 30 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034478
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| Registered date | File name |
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