UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058256 |
|---|---|
| Receipt number | R000066593 |
| Scientific Title | Preliminary Evaluation of the Association Between Sleep and Postprandial Blood Glucose Levels |
| Date of disclosure of the study information | 2025/06/23 |
| Last modified on | 2025/08/19 14:18:42 |
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Basic information
Public title
Preliminary Evaluation of the Association Between Sleep and Postprandial Blood Glucose Levels
Acronym
Preliminary Evaluation of the Association Between Sleep and Postprandial Blood Glucose Levels
Scientific Title
Preliminary Evaluation of the Association Between Sleep and Postprandial Blood Glucose Levels
Scientific Title:Acronym
Preliminary Evaluation of the Association Between Sleep and Postprandial Blood Glucose Levels
Region
| Japan |
Condition
Condition
not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the association between sleep and postprandial blood glucose levels.
Basic objectives2
Others
Basic objectives -Others
To assess the impact of sleep on postprandial glucose responses.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To examine whether glycemic control indicators are associated with sleep parameters.
Key secondary outcomes
Comparison of glycemic control indicators among subgroups defined by sleep characteristics.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Other |
Interventions/Control_1
Participants are instructed to consume a standardized breakfast (test food) as part of the intervention protocol
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Male and female over 20 years old
Key exclusion criteria
1) Persons undergoing treatment for diabetes or equivalent medical treatment (medication for blood glucose control, insulin injections, etc.).
2) Persons with food allergies to the test food.
3) Persons with implanted medical devices such as pacemakers.
4) Persons diagnosed with sleep-related disorders such as sleep apnea, insomnia, circadian rhythm sleep-wake disorders, or narcolepsy.
5) Any other person who is deemed inappropriate by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shige |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
3292762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Shigenori_Suzuki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Yosdhida |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
3292756
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Homepage URL
Haruka_Yoshida@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
KAGOME CO.,LTD, Research Ethics Review Committee
Address
3-21-1, Nihonbashi Hamacho, Chuo-ku, Tokyo
Tel
03-5623-8501
IRB @kagome.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
カゴメ株式会社総合研究所(栃木県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 23 | 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
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2025 | Year | 06 | Month | 23 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066593
