UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049000 |
|---|---|
| Receipt number | R000055820 |
| Scientific Title | A study using isCGM of second meal effect of food containing some nutrients having suppressive effect on postprandial blood glucose level |
| Date of disclosure of the study information | 2022/09/22 |
| Last modified on | 2022/09/26 14:19:56 |
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Basic information
Public title
A study using intermittently scanned continuous glucose monitoring of second meal effect of food containing some nutrients having suppressive effect on postprandial blood glucose level
Acronym
A study of second meal effect of food containing some nutrients having suppressive effect on postprandial blood glucose level
Scientific Title
A study using isCGM of second meal effect of food containing some nutrients having suppressive effect on postprandial blood glucose level
Scientific Title:Acronym
A study of second meal effect of food containing some nutrients having suppressive effect on postprandial blood glucose level
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To measure the postprandial blood glucose level and second meal effect of test food
2. To obtain knowledge about characteristics of blood glucose level after rice intake in each group divided by age and gender
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interstitial fluid glucose
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
1. Packed rice :
During the 14-day test period, the number of intakes is 2 times for breakfast and 4 times for lunch, a total of 6 times
2. Test food :
During the 14-day test period, the number of intakes is 2 times
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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females (>=20 to <=69 years of age)
(2) Subjects whose BMI values are <=30 kg/m2
(3) Subjects who have and can use smartphone (iPhone : iOS13.2 or later, Android : 10.0 or later)
Key exclusion criteria
(1) Subjects with food allergies or hypersensitivities
(2) Subjects with diseases that require constant medication, or with a medical history of severe diseases that require constant medication
(3) Subjects who have been diagnosed with medical or surgical diseases that require hospitalization in the past 3 months
(4) Subjects with disorders or taking medicine related to digestion or absorption of nutrients
(5) Subjects with a medical history of diabetes, or have been used hypoglycemic agents or insulin for treatment of diabetes or related disorders
(6) Subjects who have been diagnosed with glucose tolerance disorders in the past year
(7) Subjects who are participating in another trial, have participated in the past 4 weeks, or plan to participate in another trial during the scheduled study period
(8) Females who plan to have pregnancy or lactation
(9) Subjects judged to be inadequate by the questionnaire of lifestyles
(10) Subjects judged to be unsuitable for the study for other reasons by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kanae |
| Middle name | |
| Last name | Matsuo |
Organization
LaViena Inc.
Division name
President
Zip code
105-0021
Address
1-10-2, Higashi-shinbashi, Minato-ku, Tokyo
TEL
03-6821-1389
info@laviena.me
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Ozawa |
Organization
LaViena Inc.
Division name
-
Zip code
105-0021
Address
1-10-2, Higashi-shinbashi, Minato-ku, Tokyo
TEL
03-6821-1389
Homepage URL
info@laviena.me
Sponsor or person
Institute
LaViena Inc.
Institute
Department
Personal name
Funding Source
Organization
LaViena 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
Ethics Committees of NISHI-UMEDA Clinic for Asian Medical Collaboration
Address
3-3-45 Umeda, Kita-ku, Osaka-shi, Osaka
Tel
06-4797-5660
jimukyoku@amc-clinc.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
| 2022 | Year | 09 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 22 | Day |
Last modified on
| 2022 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055820
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| Registered date | File name |
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