UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056058 |
|---|---|
| Receipt number | R000064056 |
| Scientific Title | Mechanism of worsening post-dinner blood sugar due to lunch skipping: An exploratory study using serum component analysis |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/11/05 16:14:31 |
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Basic information
Public title
Mechanism of worsening post-dinner blood sugar due to lunch skipping: An exploratory study using serum component analysis
Acronym
Mechanism of worsening post-dinner blood sugar due to lunch skipping: An exploratory study using serum component analysis
Scientific Title
Mechanism of worsening post-dinner blood sugar due to lunch skipping: An exploratory study using serum component analysis
Scientific Title:Acronym
Mechanism of worsening post-dinner blood sugar due to lunch skipping: An exploratory study using serum component analysis
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been reported that skipping breakfast worsens blood sugar levels after lunch compared to eating breakfast, and we confirmed that skipping lunch also worsens blood sugar levels after dinner.
Furthermore, although hormonal changes related to blood sugar regulation and increases in free fatty acids have been observed in skipping breakfast, no studies have been conducted to analyze serum metabolites other than free fatty acids. It is thought that the serum metabolites of skipped lunch are chronotrophically different from the serum metabolites of skipped breakfast, and the search for this is thought to be novel.
Based on the above, in this study, we conduct an exploratory clinical study to comprehensively analyze serum metabolites, with the aim of getting closer to elucidating the mechanism of post-dinner blood sugar deterioration in patients who skip lunch.
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
Relative concentration of each molecule in plasma obtained by metabolomics/lipidomics analysis
Key secondary outcomes
Blood sugar level, plasma insulin, GLP-1 concentration, glucagon concentration
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Before the intervention starts, anthropometric, body composition, self-administered questionnaire are performed. This study protocol consists of two days control intervention-one week washout-two days test intervention. Each intervention sets the mealtime at 6-7 am (breakfast),0-1 pm (lunch), 6-7 pm (dinner). Blood is collected before the dinner at the second day of each intervention.
Interventions/Control_2
Control intervention and test intervention are transposed. Other intervention protocols are the same as the above protocol.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women over 18 years of age with a BMI of 18.5 or more and less than 25 kg/m2 and no history of diabetes.
Key exclusion criteria
1)Pregnant women
2)Smoking
3)Skipping meals
4)Food allergies
5)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 | Yuki |
| Middle name | |
| Last name | Shimba |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5561
shokuji@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Shimba |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5561
Homepage URL
shokuji@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Urakami Foundation for Food and Food Culture Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064056
