UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050527 |
|---|---|
| Receipt number | R000057525 |
| Scientific Title | A confirmation study for the change in blood glucose level: an open-label trial |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2023/03/06 14:46:25 |
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Basic information
Public title
A confirmation study for the change in blood glucose level: an open-label trial
Acronym
A confirmation study for the change in blood glucose level: an open-label trial
Scientific Title
A confirmation study for the change in blood glucose level: an open-label trial
Scientific Title:Acronym
A confirmation study for the change in blood glucose level
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the change in blood glucose level by consuming different types of confectionery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change in blood glucose level between pre- and 120 minutes after consumption
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Single ingestion
Test food1: Candy-1
Test food2: Candy-2
Test food3: Candy-3
Test food4: Gummy-1
Test food5: Gummy-2
Test food6: Cookie
Test food7: Chocolate
Test food8: Cream puff
Test food9: Daifuku (a soft rice cake stuffed with sweetened red bean jam)
Test food10: Sugared water
Test food11: Gummy-3
Test food12: Ramune soda candy
Test food13: Carbonated drink
Administration: Follow the instruction given by the head of operation and take prescribed test foods at each assessment.
Interventions/Control_2
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
8. Subjects who suffer from COVID-19
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in this study by the principal investigator or the head of operation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naruhiko |
| Middle name | |
| Last name | Hongou |
Organization
Kanro Inc.
Division name
Research Promotion Dept, Research & Technology Div.
Zip code
135-0051
Address
2-20-12 Edagawa, Koto-ku, Tokyo
TEL
03-5634-6000
Naruhiko_hongou@kanro.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Sugimura |
Organization
Kanro Inc.
Division name
Research Promotion Dept, Research & Technology Div.
Zip code
135-0051
Address
2-20-12 Edagawa, Koto-ku, Tokyo
TEL
03-5634-6000
Homepage URL
Eiji_sugimura@kanro.jp
Sponsor or person
Institute
Kanro Inc.
Institute
Department
Personal name
Funding Source
Organization
Kanro Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.com
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
| 2024 | Year | 02 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057525
| 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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