UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043287 |
|---|---|
| Receipt number | R000049421 |
| Scientific Title | Effects of differences in calorie intake and nutrient balance at lunch on blood glucose fluctuations |
| Date of disclosure of the study information | 2021/02/09 |
| Last modified on | 2024/03/17 21:53:03 |
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Basic information
Public title
Effects of differences in calorie intake and nutrient balance at lunch on blood glucose fluctuations
Acronym
Effects of differences in calorie intake and nutrient balance at lunch on blood glucose fluctuations
Scientific Title
Effects of differences in calorie intake and nutrient balance at lunch on blood glucose fluctuations
Scientific Title:Acronym
Effects of differences in calorie intake and nutrient balance at lunch on blood glucose fluctuations
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the influence of calorie intake and nutrient balance at lunch on second meal effect focusing on diurnal variation of blood glucose
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following measures would be conducted before and after 2 weeks intervention
1) evaluation of biological rhythm by glucose measurements by flash glucose monitoring system
Key secondary outcomes
1) Background survey
2) height
3) weight
4) body composition
5) food frequency questionnaire
6) food intake record
7) morningness-eveningness type / Pittsburgh sleep quality index
8) physical activity measured by accelerometer or activity meter
9) blood pressure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Low-calorie intake at lunch
Interventions/Control_2
Average-calorie intake at lunch
Interventions/Control_3
High-calorie intake at lunch
Interventions/Control_4
High protein intake at lunch
Interventions/Control_5
High fat intake at lunch
Interventions/Control_6
High carbohydrate intake at lunch
Interventions/Control_7
Lunch skipping
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
Men or women in 20-30 who agreed with the research purpose meet the following requirements.
1)who does not have a change in lifestyle in intervention term
2)who can wear a glucose monitor, an activity monitor, and eat test meal at a specific time
3)who does not have the custom to exercise
Key exclusion criteria
1) To take medicine related to psychotropic, sleeping, steroid
2) Obesity (BMI>35kg/m2) and sleep apnea syndrome
3) High blood pressure (SBP: above140mmHg, and DBP: above 90mmHg)
4) To take medicine related to diabetes and hyperlipidemia
5) The principal investigator or the principal doctor judge the subject as inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | shigenobu |
| Middle name | |
| Last name | Shibata |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
162-8480
Address
2-2 Wakamatsu, Shinjuku, Tokyo
TEL
03-5369-7318
shibatas@waseda.jp
Public contact
Name of contact person
| 1st name | Hyeon-Ki |
| Middle name | |
| Last name | Kim |
Organization
Waseda University
Division name
School of Advanced Science and Engineering
Zip code
162-8480
Address
2-2 Wakamatsu, Shinjuku, Tokyo
TEL
03-5369-7318
Homepage URL
gusrlgusrl82@gmail.com
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
1-104 Totsukamachi, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2021 | Year | 02 | Month | 09 | 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
32
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
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2021 | Year | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049421
