UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056148 |
|---|---|
| Receipt number | R000049880 |
| Scientific Title | Change in glucose level after consuming Nippuku-meshi. - Comparison with convenience store side dishes - |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2024/11/13 17:09:27 |
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Basic information
Public title
Change in glucose level after consuming Nippuku-meshi.
- Comparison with convenience store side dishes -
Acronym
Change in glucose level after consumption of Nippuku-meshi and convenience store side dishes
Scientific Title
Change in glucose level after consuming Nippuku-meshi.
- Comparison with convenience store side dishes -
Scientific Title:Acronym
Change in glucose level after consumption of Nippuku-meshi and convenience store side dishes
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of changes in glucose levels after consumption of Nippuku-meshi and convenience store prepared foods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subcutaneous interstitial fluid glucose level
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1. Nippuku-meshi
Nippuku A food
Boiled beef
Fried gomoku vegetables set
Lettuce salad
Octopus and broccoli basil salad
Boiled mackerel
Rice
Nippuku B food
Boiled mackerel in miso
Radish mixed salad
Rice
Nippuku C food
Grilled mackerel with salt
Octopus and broccoli basil salad
Radish mixed salad
Rice
Interventions/Control_2
2. Convenience store side dish
A day
Beef bowl
Seven kinds of miso soup
B day
Grilled Mackerel with salt bento
Miso soup with seaweed
C day
Starchy sauce rice bowl
Shrimp and broccoli salatd with vegitable tartar sauce
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
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Those who can measure subcutaneous interstitial fluid glucose
2.Those who can cook
3.Those who can maintain the same life rhythm for 10 days
4.Non-smokers
5.Those who have experience eating convenience store side dishes
Key exclusion criteria
1.Those who have been instructed to restrict food intake by a doctor
2.Those who are taking medication (diabetes, cardiovascular disease, cancer, etc.)
3.Those who belong to the athletic club
4.Those who can't stop drinking
5.Those who have food allergies
6.Those who have experienced skin irritation due to alcohol disinfection
7.Those who have a pacemaker or other implantable medical device in the body
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Yamamoto |
Organization
Nihon Fukushi University
Division name
Department of Sport Sciences
Zip code
470-3295
Address
35-6 Aza-Egemae, Ooaza-Okuda, Mihama-cho,Chita-gun, Aichi-pref, JAPAN
TEL
0569-87-2211
kazuey@n-fukushi.ac.jp
Public contact
Name of contact person
| 1st name | Kazue |
| Middle name | |
| Last name | Yamamoto |
Organization
Nihon Fukushi University
Division name
Department of Sport Sciences
Zip code
470-3295
Address
35-6 Aza-Egemae, Ooaza-Okuda, Mihama-cho,Chita-gun, Aichi-pref, JAPAN
TEL
0569-87-2211
Homepage URL
kazuey@n-fukushi.ac.jp
Sponsor or person
Institute
Nihon Fukushi University
Institute
Department
Personal name
Funding Source
Organization
Nihon Fukushi University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon Fukushi University
Address
35-6 Aza-Egemae, Ooaza-Okuda, Mihama-cho,Chita-gun, Aichi-pref, JAPAN
Tel
0569-87-2211
kazuey@n-fukushi.ac.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
日本福祉大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 01 | 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
18
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
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049880
