UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048223 |
|---|---|
| Receipt number | R000054953 |
| Scientific Title | Effects of meal timing on energy metabolism |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/07/01 15:56:46 |
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Basic information
Public title
Elucidation of effects of meal timing on energy metabolism
Acronym
Elucidation of effects of meal timing on energy metabolism
Scientific Title
Effects of meal timing on energy metabolism
Scientific Title:Acronym
Effects of meal timing on energy metabolism
Region
| Japan |
Condition
Condition
Adult men
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify effects of meal timing on each component of energy expenditure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24-hours glucose concentration
Key secondary outcomes
Glucose concentration indices, 24-hours glucose standard deviation.
energy expenditure
substrate oxidation
physical activity
Appetite, visual analogue scale
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. Control meal time (breakfast:7:30-8:30, lunch: 12:00-13:00, dinner:19:00-20:00).
Wash out 1 week.
2. Night type meal time(lunch:11:30-13:30, dinner:16:00-17:00, midnight meal: 23:00-0:00)
Interventions/Control_2
1. Night type meal time(lunch: 11:30-13:30, dinner: 16:00-17:00, midnight snack: 23:00-0:00).
Wash out 1 week.
2. Control meal time(breakfast: 7:30-8:30, lunch:12:00-13:00, dinner:19:00-20:00).
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
Key inclusion criteria
1. Subjects who can make self-judgment and are voluntarily giving written informed consent.
2. BMI range: 18.5-30.0 kg/m2
3. Healthy subjects
4. Who is approved participation by the doctor
Key exclusion criteria
1. BMI range: 18.5-30.0 kg/m2
2. Who are not prohibited from exercising by a doctor.
3. Subjects who have diagnostic of mental disorder
4. Subjects who have past surgical history of gastroenterological surgery.
5. Past medical history of kidney disease.
6. Subjects who use pharmaceuticals regularly.
7. Subjects who excessive alcohol intake
and who have a smoking habit.
8. Subjects who is irregular eating habits.
9. Subjects who are participating or will participate other clinical trials.
10. Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Hatamoto |
Organization
National Institute of Health, and Nutrition, National Institutes of Biomedical Innovation, Health, and Nutrition
Division name
Department of Nutrition and Metabolism
Zip code
1628636
Address
1-23-1 Toyama, Shinjuku-ku
TEL
+81332035725
yhatamoto@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | YOICHI |
| Middle name | |
| Last name | HATAMOTO |
Organization
Fukuoka University
Division name
Institute for Physical Activity
Zip code
8140180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
+81928716631
Homepage URL
yhatamoto@nibiohn.go.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
same as above
Address
same as above
Tel
0928716631
pj.ca.u-akoukuf.mda@nisius
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
| 2022 | Year | 07 | Month | 01 | 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
8
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
| 2018 | Year | 05 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 03 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054953
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
