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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035366
Receipt No. R000040302
Scientific Title Study for inhibitory effect on increase in postprandial blood glucose level by ingestion of dry sprout
Date of disclosure of the study information 2018/12/26
Last modified on 2019/03/27

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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
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
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

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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