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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030186
Receipt No. R000034478
Scientific Title Examination on a transition in a post-meal blood sugar level by three dietary methods(examination on soy first effects)
Date of disclosure of the study information 2017/12/01
Last modified on 2018/03/01

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Basic information
Public title Examination on a transition in a post-meal blood sugar level by three dietary methods(examination on soy first effects)
Acronym Examination on a transition in a post-meal blood sugar level by three dietary methods(examination on soy first effects)
Scientific Title Examination on a transition in a post-meal blood sugar level by three dietary methods(examination on soy first effects)
Scientific Title:Acronym Examination on a transition in a post-meal blood sugar level by three dietary methods(examination on soy first effects)
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine transitions in the post-meal blood sugar level among healthy males and females aged 30 and over, below 50 by three dietary methods.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Post-meal blood sugar level
2)Survey on fullness
3)AUC (Area Under Curve)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 On the day intake of the two of warmed rice balls within 8 minutes.
Interventions/Control_2 On the day intake of the two of warmed rice balls after finished eating the salad within 13 minutes.
Interventions/Control_3 On the day intake of the two of warmed rice balls after finished eating the boiled soybeans within 13 minutes.
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
50 years-old >
Gender Male and Female
Key inclusion criteria 1)Age:30 and over, below 50.
2)Sex:Males and females with Japanese nationality.
3)BMI of 22 and over, below 25.
4)Consumption of carbohydrates in three meals a day.
Key exclusion criteria 1)Currently in treatment with medication, or currently in exercise therapy and/or dietary therapy under medical supervision.
2)Previous history of hepatic disorder, severe kidney, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disorder, or a complication of these.
3)Arrhythmia or serious anemia.
4)Use of a coagulant.
5)Symptoms of dizziness, lightheadedness, palpitation, headache, breathlessness, etc.
6)Presence or previous history of hepatitis.
7)Current intake of a health food product or a supplement that has an influence on the blood sugar level.
8)Pregnant or nursing.
9)Presence or previous history of mental disorder (depression, etc.).
10)Presence or previous history of allergic reaction to medication or a food product.
11)Working on night shift or with alternative work schedule.
12)Participation in any other clinical study involving human subjects within 3 months or current participation in any other clinical study involving human subjects.
13)Subjects who are deemed to be unsuitable by the investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Email ochitani@huma-c.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Homepage URL
Email ochitani@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Integrate 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
2017 Year 12 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
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
2017 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 30 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034478

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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