UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039932 |
|---|---|
| Receipt number | R000045537 |
| Scientific Title | Study of meal timing on postprandial interstitial fluid glucose levels |
| Date of disclosure of the study information | 2020/03/25 |
| Last modified on | 2020/09/23 10:21:25 |
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Basic information
Public title
Study of meal timing on postprandial interstitial fluid glucose levels
Acronym
Study of meal timing on postprandial interstitial fluid glucose levels
Scientific Title
Study of meal timing on postprandial interstitial fluid glucose levels
Scientific Title:Acronym
Study of meal timing on postprandial interstitial fluid glucose levels
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of meal timing on postprandial interstitial fluid glucose levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interstitial fluid glucose levels
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
The same meal three times a day consecutively, thereby satisfying their daily energy requirements
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals whose BMI is between 18.5-25.
2) Individuals who are not have life style related diseases.
3) Individuals who avoid excessive exercise. during the intervention period.
4) Individuals who aged 20-65.
Key exclusion criteria
1) Individuals who have week skin and get a skin rash after bandage.
2) Individuals who are or are possibly pregnant, or are lactating.
3) Individuals who use an implantable medical devices such as pacemakers.
4)Individuals who excessively take alcohol (expressed in an amount of alcohol: over 20g/day).
5)Individuals who are a smoker.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Yoshida |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
4228526
Address
52-1Yada Suruga-ku Shizuoka 422-8526, Japan
TEL
0542645561
t-yoshida@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Yoshida |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
4228526
Address
52-1Yada Suruga-ku Shizuoka 422-8526, Japan
TEL
0542645561
Homepage URL
t-yoshida@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka
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
University of Shizuoka
Address
52-1Yada Suruga-ku, Shizuoka, Japan
Tel
0542645561
rinri@u-shizuoka-ken.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 25 | 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
9
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 | 03 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 08 | 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
| 2020 | Year | 03 | Month | 25 | Day |
Last modified on
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045537
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
