UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061316 |
|---|---|
| Receipt number | R000070020 |
| Scientific Title | Glycemic Variability of consuming late-night carbohydrate intake: A Randomized Crossover Study in healthy young women |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/04/20 09:58:30 |
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Basic information
Public title
Glycemic Variability of consuming late-night carbohydrate intake: A Randomized Crossover Study in healthy young women
Acronym
Glycemic Variability of consuming late-night carbohydrate intake
Scientific Title
Glycemic Variability of consuming late-night carbohydrate intake: A Randomized Crossover Study in healthy young women
Scientific Title:Acronym
Glycemic Variability of consuming late-night carbohydrate intake
Region
| Japan |
Condition
Condition
healthy women
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effects of a divided-meal pattern, vegetables and protein consumed at 18:00, followed by vegetables and carbohydrates at 21:00 on glycemic responses in healthy young women using continuous glucose monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome was MAGE.
Key secondary outcomes
The secondary outcome was the IAUC for glucose.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dinner is administered under three different timing and eating-pattern conditions.
21:00 dinner, in which the entire dinner is consumed at 21:00 in the following order over a 20-minute period: the side dish (vegetables), the main dish (protein-rich food), and rice (carbohydrates);
Interventions/Control_2
Carbohydrate-first divided dinner, in which rice is consumed at 18:00 and the main and side dishes at 21:00
Interventions/Control_3
Carbohydrate-last divided dinner, in which the main and side dishes are consumed at 18:00 and rice at 21:00.
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy female undergraduate students at the university are recruited as volunteers. Only individuals who is confirmed not to have diabetes are eligible for inclusion.
Key exclusion criteria
Individuals who are pregnant, suspected of being pregnant, or taking medications known to affect glucose metabolism were excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Women's University
Division name
department of Food and Nutrition, Faculity of Home Economics
Zip code
605-8501
Address
35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
TEL
075-531-7128
imais@kyoto-wu.ac.jp
Public contact
Name of contact person
| 1st name | Saeko |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Women's University
Division name
Department of Food and Nutrition, Faculity of Home Economics
Zip code
605-8501
Address
35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
TEL
075-531-7128
Homepage URL
imais@kyoto-wu.ac.jp
Sponsor or person
Institute
Kyoto Women's University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Women's 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
Kyoto Women's University
Address
35, Kitahiyoshi-cho, Imakumano, Higashiyama-ku, Kyoto
Tel
075^531-7128
imais@kyoto-wu.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
京都女子大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 21 | 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
20
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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 20 | Day |
Last modified on
| 2026 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070020
