UMIN-CTR Clinical Trial

Basic information
Public title	Study for inhibitory effect on increase in postprandial blood glucose level by ingestion of dry sprout
Acronym	Study for inhibitory effect on increase in postprandial blood glucose level by ingestion of sprout
Scientific Title	Study for inhibitory effect on increase in postprandial blood glucose level by ingestion of dry sprout
Scientific Title:Acronym	Study for inhibitory effect on increase in postprandial blood glucose level by ingestion of sprout
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify inhibitory effect on increase in postprandial blood glucose level by ingesting dry sprout.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time course of blood glucose concentration changes before and after ingesting of dry sprout or test food(C, Cmax, Tmax, deltaAUC) *Measure at before ingestion and 30, 60, 90, and 120 minutes after ingestion.
Key secondary outcomes	Time course of blood insulin concentration changes before and after ingesting of dry sprout and test food(C, Cmax, Tmax, deltaAUC) *Measure at just before ingestion and 30, 60, 90, and 120 minutes after ingestion. Blood penicidine concentration Physical examination (body weight, blood pressure, pulse rate, BMI) Questionnaire for subject background, excise and meal at the previous day, and physical condition and meal at the test day.

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects ingest any one of A to C test food once a day. After about one week washout, subjects ingest another test food once a day. After a further week washout, subjects ingest the other test food once a day. Test food A : Dry sprout 4.3 g, Rice 150 g, Retort curry 180 g Test food B : Control dry sprout 4.3 g, Rice 150 g, Retort curry 180 g Test food C : Rice 150 g, Retort curry 180 g Test food A > (about one week) > Test food B > (about one week) > Test food C
Interventions/Control_2	Test food B > (about one week) > Test food C > (about one week) > Test food A
Interventions/Control_3	Test food C > (about one week) > Test food A > (about one week) > Test food B
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	65 years-old >
Gender	Female
Key inclusion criteria	1. Healthy Japanese women over 20 years old and under 65 at the time of consent acquisition 2. Those whose BMI less than 25 at the time of screening 3. Those whose blood glucose concentration is less than 126 mg/dL at the time of screening 4. Those whose blood HbA1c is less than 6.5% at the time of screening 5. Those who apply to 4 and are top 30 of numerical value of HbA1c.
Key exclusion criteria	1. Those who have a chronic disease and are undergoing medication, those with a serious disease history 2. Those who are allergic to the test food 3. Those who regularly use medicines, specific insurance foods, health foods, etc. that may affect blood glucose levels 4. Those who have participated in other tests within the first month before the start of the exam, or who are planning to participate in other exams after this exam consent 5. Those who are judged ineligible at the discretion of the examining supervisor and research leader 6. Those who are breast-feeding, pregnant, and are planning or hoping pregnancy during the exam
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takamasa Masuda
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Email	masudat@hc-sys.jp

Public contact
1st name of contact person	1st name Middle name Last name Takamasa Masuda
Organization	Healthcare Systems Co., Ltd.
Division name	Research and Development Department
Zip code
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Homepage URL
Email	masudat@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization	Saladcosmo 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
Email

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	2018 Year 12 Month 26 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	2018 Year 12 Month 26 Day
Date of IRB	2018 Year 12 Month 26 Day
Anticipated trial start date	2018 Year 12 Month 26 Day
Last follow-up date	2019 Year 02 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 26 Day
Last modified on	2019 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040302