UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000039564