UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034776 |
|---|---|
| Receipt number | R000039564 |
| Scientific Title | Inhibitory effect on elevation of blood glucose level by bonito dashi |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/05/10 11:55:44 |
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Basic information
Public title
Inhibitory effect on elevation of blood glucose level by bonito dashi
Acronym
Inhibitory effect on elevation of blood glucose level by bonito dashi
Scientific Title
Inhibitory effect on elevation of blood glucose level by bonito dashi
Scientific Title:Acronym
Inhibitory effect on elevation of blood glucose level by bonito dashi
Region
| Japan |
Condition
Condition
Men and women aged from 30 to 70
without a critical disease such as diabetes mellitus and having BMI less than 30.
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze inhibitory effect on elevation of blood glucose level by bonito dashi in adults without a critical disease such as diabetes mellitus and having BMI less than 30.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
After measuring of fasting blood glucose levels of volunteers, they ingest bonito dashi (150 ml). After 30 min later, the volunteer's blood glucose levels are measured again. Then, they eat cooked and packaging rice (295 kcal). After eating the rice, their blood glucose levels are measured with 15~30 min intervals up to 150 min.
Instead of bonito dashi, the case of mineral water-drinking is its control.
Interventions/Control_2
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy male and female volunteers
2.From 30 to 70 years of age
3.Be able to provide written informed consent
Key exclusion criteria
With a critical disease such as diabetes mellitus
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Suzuki |
Organization
Tenshi College
Division name
School of Nursing and Nutrition
Zip code
065-0013
Address
Higashi-ku, Kita-13 Higashi -3, Sapporo, Japan
TEL
011-741-1051
j-suzuki@tenshi.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Suzuki |
Organization
Tenshi College
Division name
School of Nursing and Nutrition
Zip code
065-0013
Address
Higashi-ku, Kita-13 Higashi -3, Sapporo, Japan
TEL
011-741-1051
Homepage URL
j-suzuki@tenshi.ac.jp
Sponsor or person
Institute
Tenshi College, School of Nursing and Nutrition, Department of Nutrition
Institute
Department
Personal name
Funding Source
Organization
Rworks inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tenshi College, Research ethics committee
Address
Higashi-ku, Kita-13 Higashi -3, Sapporo, Japan
Tel
011-741-1051
kubota@tenshi.ac.jp
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
天使大学（北海道） Tenshi College (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | 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
20
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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 05 | Day |
Last modified on
| 2019 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039564
