UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054455 |
|---|---|
| Receipt number | R000062180 |
| Scientific Title | Exploratory Study of the Effect of Food Ingredient Intake on Postprandial Blood Glucose Levels -Open-Label Crossover Study- |
| Date of disclosure of the study information | 2024/05/24 |
| Last modified on | 2024/11/12 12:34:04 |
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Basic information
Public title
Exploratory Study of the Effect of Food Ingredient Intake on Postprandial Blood Glucose Levels
-Open-Label Crossover Study-
Acronym
Exploratory Study of the Effect of Food Ingredient Intake on Postprandial Blood Glucose Levels
-Open-Label Crossover Study-
Scientific Title
Exploratory Study of the Effect of Food Ingredient Intake on Postprandial Blood Glucose Levels
-Open-Label Crossover Study-
Scientific Title:Acronym
Exploratory Study of the Effect of Food Ingredient Intake on Postprandial Blood Glucose Levels
-Open-Label Crossover Study-
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of food ingredients on suppressing postprandial blood sugar levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cmax of blood glucose
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food: Total 10 types
Intake: Each test foods will be consumed once
* The order in which the test foods are consumed is set to six different patterns
Interventions/Control_2
Test food: Total 10 types
Intake: Each test foods will be consumed once
* The order in which the test foods are consumed is set to six different patterns
Interventions/Control_3
Test food: Total 10 types
Intake: Each test foods will be consumed once
* The order in which the test foods are consumed is set to six different patterns
Interventions/Control_4
Test food: Total 10 types
Intake: Each test foods will be consumed once
* The order in which the test foods are consumed is set to six different patterns
Interventions/Control_5
Test food: Total 10 types
Intake: Each test foods will be consumed once
* The order in which the test foods are consumed is set to six different patterns
Interventions/Control_6
Test food: Total 10 types
Intake: Each test foods will be consumed once
* The order in which the test foods are consumed is set to six different patterns
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females in the age between 30 and 64 years
(2) Subjects who can have explanations and examinations in a remote environment (web conference system, web questionnaire, etc.)
(3) Subjects who can come to the designated examination facility on the scheduled visit date
(4) Subjects who can submit the written informed consent form
Key exclusion criteria
(1) Subjects who regularly consume pharmaceuticals or quasi-drugs that may affect the efficacy evaluation of the test food
(2) Subjects who continuously consume food for specified health use, functional foods, or health foods that may affect the efficacy evaluation of the test food
(3) Subjects whose lifestyle is scheduled to change drastically before or after the start of the study (including business trip, travel, etc. that will significantly change the rhythm of their daily life)
(4) Subjects who are currently participating in another study as a study subject, who have participated in another study within 4 weeks of its completion, or who schedule to participate in another study during the study period
(5) Other subjects who are judged by the investigator as unsuitable for the study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Watanabe Hospital
Division name
Surgery
Zip code
144-0043
Address
1-5-6, Haneda, Ota-ku, Tokyo, 144-0043, JAPAN
TEL
03-3741-0223
wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Koizumi |
Organization
Apoplus Station Co., Ltd.
Division name
CRO Department Clinical Operations Division
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027, JAPAN
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
Apoplus Station Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kanamori Giken 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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
food-contact@apoplus.co.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
| 2024 | Year | 05 | Month | 24 | 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
| 2024 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe how different supplement intake habits affect postprandial blood glucose fluctuations
Management information
Registered date
| 2024 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062180
