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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034776
Receipt No. 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

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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
Email 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
Email j-suzuki@tenshi.ac.jp

Sponsor
Institute Tenshi College, School of Nursing and Nutrition, Department of Nutrition
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039564

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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