UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040370 |
|---|---|
| Receipt number | 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 | 2020/11/10 13:51:38 |
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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
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
kobayashi@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
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
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
10
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
| 2020 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 02 | Day |
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 | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046072
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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