UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042542 |
|---|---|
| Receipt number | R000048565 |
| Scientific Title | Effects of meal timing and content on glycemic fluctuations and metabolic responses |
| Date of disclosure of the study information | 2020/11/25 |
| Last modified on | 2021/03/23 13:23:08 |
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Basic information
Public title
Effects of meal timing and content on glycemic fluctuations and metabolic responses
Acronym
Effects of meal timing and content on glycemic fluctuations and metabolic responses
Scientific Title
Effects of meal timing and content on glycemic fluctuations and metabolic responses
Scientific Title:Acronym
Effects of meal timing and content on glycemic fluctuations and metabolic responses
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of meals timing and content on glycemic fluctuations and metabolic responses
Basic objectives2
Others
Basic objectives -Others
To clarify the effects of meals timing and content on glycemic fluctuations and metabolic responses
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glucose; Respiratory quotient
Key secondary outcomes
Glucose-related parameters
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Other |
Interventions/Control_1
Different meal times (18:00 vs. 21:00)
Period; 3 days
Interventions/Control_2
Different meal contents (standard meal vs. high fat meal)
Period; 3 days
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults
2.Nonsmoker
Key exclusion criteria
Those who are taking medication
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Yoshimura |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental & Symbiotic Sciences
Zip code
862-8502
Address
3-1-100 Tsukide Higashi-ku, Kumamoto
TEL
0963832929
eyoshi@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Ishii |
Organization
Prefectural University of Kumamoto
Division name
Regional Cooperation Policy Center
Zip code
862-8502
Address
3-1-100 Tsukide Higashi-ku, Kumamoto
TEL
0963832929
Homepage URL
renkei-c@pu-kumamoto.ac.jp
Sponsor or person
Institute
Prefectural University of Kumamoto
Institute
Department
Personal name
Funding Source
Organization
Support Organization for Securing Stable Supply of Rice
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Regional Cooperation Policy Center
Address
3-1-100 Tsukide Higashi-ku, Kumamoto
Tel
0963832929
renkei-c@pu-kumamoto.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
| 2020 | Year | 11 | Month | 25 | 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
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
| 2019 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 12 | 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
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048565
