UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054192 |
|---|---|
| Receipt number | R000061883 |
| Scientific Title | Interventional study on the effects of meal skipping on blood glucose variability |
| Date of disclosure of the study information | 2024/04/22 |
| Last modified on | 2024/04/18 15:53:16 |
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Basic information
Public title
Effect of meal skipping on subsequent postprandial glucose levels
Acronym
Effect of meal skipping on subsequent postprandial glucose levels
Scientific Title
Interventional study on the effects of meal skipping on blood glucose variability
Scientific Title:Acronym
Interventional study on the effects of meal skipping on blood glucose variability
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been reported that skipping breakfast leads to increasing of postprandial glucose levels. Previous studies have shown that extending the fasting time affects blood glucose fluctuations. However, the reports regarding skipping lunch and dinner are limited. Additionally, in recent years, habitual skipping of lunch or dinner, not just breakfast, has been increasing among young people. These facts indicate that the research necessity of postprandial glucose effects in lunch or dinner skipping. In this study, we examine the effects of skipping breakfast, lunch, and dinner on subsequent glycemic excursions in healthy subjects.
Basic objectives2
Others
Basic objectives -Others
Examine how specific dietary habits affect glycemic excursion
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in postprandial blood glucose obtained by intermittently scanned continuous glucose monitoring
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 | Behavior,custom |
Interventions/Control_1
Research period is for 14 days.
Patients wear an intermittently scanned continuous glucose monitoring devices (isCGM) on their upper arm. Mealtimes are: 7:00 (breakfast), 13:00 (lunch), 19:00 (dinner).Meal contents are not fixed in this three meal times, prohibited snacks and sweetened drink outside of meal times. Dietary record is by meal photo and weigh high-carbohydrate foods, including staple foods. Meal skipping intervention is day 3-4 (breakfast), day 7-8 (lunch), day 11-12 (dinner). Time to sleep is 24:00, awake time is 7:00. Alcohol consumption and excessive exercise are prohibited from 2 days from the study.
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects
1 Healthy students aged 20 years or older
2 No history of metabolic diseases
Key exclusion criteria
1 The skin rashes easily
2 Pregnancy
3 Using implanted medical devices
4 Active drinking
5 Smoking
6 Habitual skippers
7 Family history of diabetes within the second degree
8 Those who the research director judges to be inappropriate for research participation
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Hosaka |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka, Japan
TEL
054-264-5567
toshio.hosaka@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Hosaka |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka, Japan
TEL
054-264-5567
Homepage URL
toshio.hosaka@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
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka, 422-8526, Japan
Tel
054-264-5103
tyous10@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
静岡県立大学（静岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | 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
13
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
| 2020 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 30 | 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 | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061883
