UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050756 |
|---|---|
| Receipt number | R000057754 |
| Scientific Title | Investigation of changes in postprandial blood glucose by extending meal intervals |
| Date of disclosure of the study information | 2023/04/04 |
| Last modified on | 2023/04/03 16:26:18 |
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Basic information
Public title
Effects of extended time between lunch and dinner on postprandial and 24-hour blood glucose changes
Acronym
Effects of extended time between lunch and dinner on changes in blood glucose
Scientific Title
Investigation of changes in postprandial blood glucose by extending meal intervals
Scientific Title:Acronym
Effects of extended meal intervals on changes in blood glucose
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, many studies have been conducted on how to take meals, and interest is increasing from the viewpoint of diabetes treatment and prevention. Previous studies have shown that postprandial blood glucose level increase and 24-hour blood glucose control is poor due to delayed meal times, suggesting that extending the meal interval affects blood glucose fluctuations. However, the effect of extending the meal interval within 3 hours, which is considered to occur frequently within the range of daily meal times, on blood glucose fluctuations has not been investigated. This study examines the effect of delaying dinner and extending the interval between lunch and dinner by 1-3 hours on glycemic excursions in healthy subjects.
Basic objectives2
Others
Basic objectives -Others
Examine how specific dietary habits affect blood glucose variability
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
Educational,Counseling,Training
Type of intervention
| Food | Device,equipment | Behavior,custom |
Interventions/Control_1
On the first day of the study, subjects wore intermittently scanned continuous glucose monitoring devices (isCGM) on their upper arm. Meal times were fixed at 7:00 for breakfast, 13:00 for lunch, and 19:00 for dinner for the two days after the start of the study, and washout periods. Dinner time was then delayed to 20:00, 21:00, or 22:00 in random order. Each condition of dinner time was performed for 2 days, and a washout period of 2 days was provided between conditions. All participants were assigned a dinner time order by lottery in an envelope. On the last day, the isCGM devices were removed. During the study period, participants were asked to prepare their breakfast, and photographs were taken before meals in order to identify problems with the content and amount of meals. Test meals were provided for lunch and dinner. Participants were instructed to go to bed by 24:00 and wake up by 7:00 during the study period. Alcohol consumption and excessive exercise were prohibited two days before starting the study. Additionally, snacks and beverages other than water, green tea, and tea were not allowed to consume.
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 were healthy university students aged 20 years or older, with a BMI (body mass index) of less than 25 kg/m2, without a history of metabolic diseases such as diabetes, hypertension, dyslipidemia, and hyperuricemia.
Key exclusion criteria
1) Active drinking
2) Smoking
3) Food allergies
4) Family history of diabetes within the second degree
5) Pregnancy
6) Using implanted medical devices
7) Taking medicines or supplements that known to affect glucose metabolism
8) The skin rashes easily
9) Those who the research director judges to be inappropriate for research participation
Target sample size
15
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
TEL
054-264-5102
inquiry@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
TEL
054-264-5567
Homepage URL
toshio.hosaka@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Toshio Hosaka
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
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
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
| 2022 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 02 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 09 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 03 | Day |
Last modified on
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057754
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