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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040370
Receipt No. R000046072
Scientific Title Study on the influence of on time-dependent change of blood glucose level by palm sugar and brown sugar, etc. intake.
Date of disclosure of the study information 2020/05/11
Last modified on 2020/05/11

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Basic information
Public title Study on the influence of on time-dependent change of blood glucose level by palm sugar and brown sugar, etc. intake.
Acronym Study on the influence of on time-dependent change of blood glucose level by palm sugar and brown sugar, etc. intake.
Scientific Title Study on the influence of on time-dependent change of blood glucose level by palm sugar and brown sugar, etc. intake.
Scientific Title:Acronym Study on the influence of on time-dependent change of blood glucose level by palm sugar and brown sugar, etc. intake.
Region
Japan

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

Objectives
Narrative objectives1 Evaluate the time-dependent change of blood glucose level caused by intaking palm sugar and brown sugar, etc
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 a single ingesting (delta AUC, delta Cmax, delta C, Tmax)
Measure at before ingestion and 15, 30, 45, 60, 90, and 120 minutes after ingestion.
Key secondary outcomes none

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of palm sugar 52.8g
Washout for 1day or more
Intake of brown sugar 53.9g
Washout for 1day or more
Intake of white sugar 50.4g
Washout for 1day or more
Intake of glucose 50.0g
Interventions/Control_2 Intake of brown sugar 53.9g
Washout for 1day or more
Intake of white sugar 50.4g
Washout for 1day or more
Intake of glucose 50.0g
Washout for 1day or more
Intake of palm sugar 52.8g
Interventions/Control_3 Intake of white sugar 50.4g
Washout for 1day or more
Intake of glucose 50.0g
Washout for 1day or more
Intake of palm sugar 52.8g
Washout for 1day or more
Intake of brown sugar 53.9g
Interventions/Control_4 Intake of glucose 50.0g
Washout for 1day or more
Intake of palm sugar 52.8g
Washout for 1day or more
Intake of brown sugar 53.9g
Washout for 1day or more
Intake of white sugar 50.4g
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
50 years-old >=
Gender Male and Female
Key inclusion criteria 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who are 20 years old or more and 50 years old or less
3.Persons whose BMI is 30.0 or less
4.Persons who do not have impaired glucose tolerance in the past year examination (As a result of medical checkup, persons with a fasting blood glucose of less than 110 mg / dL and HbA1c of less than 5.6%)
5.Persons who are not taking drugs such as anti-hypertensive agents
Key exclusion criteria 1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who usually take a large amount of test food
4.Persons who usually take medicine, specified health food, healthy food
5.Persons who participated in other examination during the first month before the start of the exam, or those who plan to participate in other exams following this exam agreement
6.Persons who are judged inappropriate for the exam by the principal investigator
7.Persons who are breastfeeding, pregnant, scheduled or hoping to be pregnant during the exam period
8.Persons who may become menstrual period during the test period
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hirohito
Middle name
Last name Ishikawa
Organization Healthcare Systems Co., Ltd.
Division name Research and Development Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email ishikawa@hc-sys.jp

Public contact
Name of contact person
1st name Yukari
Middle name
Last name Kobayashi
Organization Healthcare Systems Co., Ltd.
Division name Sales Planning Department
Zip code 105-0004
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 070-1450-5470
Homepage URL
Email kobayashi@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization KANERYO Sea Vegetable Corporation
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 The Ethics Committee of Healthcare Systems Co., Ltd.
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel 03-6809-2722
Email soumu@hc-sys.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

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 11 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 Preinitiation
Date of protocol fixation
2020 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2020 Year 05 Month 11 Day
Last follow-up date
2020 Year 05 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 11 Day
Last modified on
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046072

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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