UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048221 |
|---|---|
| Receipt number | R000054955 |
| Scientific Title | Effects of high protein intake at breakfast on diurnal blood glucose responses |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/12/31 11:49:19 |
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Basic information
Public title
Effects of high protein intake at breakfast on diurnal blood glucose responses
Acronym
Effects of high protein intake at breakfast on diurnal blood glucose responses
Scientific Title
Effects of high protein intake at breakfast on diurnal blood glucose responses
Scientific Title:Acronym
Effects of high protein intake at breakfast on diurnal blood glucose responses
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to examine the effects of high protein intake at breakfast on diurnal blood glucose responses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Acute ingestion of placebo at breakfast
Interventions/Control_2
Acute ingestion of placebo at breakfast (lunch skipping)
Interventions/Control_3
Acute ingestion of high protein intake at breakfast
Interventions/Control_4
Acute ingestion of high protein intake at breakfast (lunch skipping)
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
20 years-old <=, 40 years-old >
Obtained written informed consent from the participant before participation
Key exclusion criteria
1) Diagnosed with diabetes and dyslipidemia by a doctor and on medication or supplementation that influence metabolism
2) Those who are an anti-depressant, insomnia medication and steroid are excluded. Those suffering from sleep apnea syndrome and obese (BMI>35kg/m2) are also excluded
3) Smoker
4) Those who have pacemaker or any other metal implant internally / externally (except silver teeth implant)
5) Those who perform shift work/ travel 2 weeks before intervention
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama Meguro, Tokyo
TEL
03-5734-2904
takahashi.m.bp@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama Meguro, Tokyo
TEL
03-5734-2904
Homepage URL
takahashi.m.bp@m.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Administrative office of Human Subjects Research Ethics Review Committee c/o: Research Safety Management Group, Research Planning Division, Research Promotion Department, Tokyo Institute of Technology
Address
2-12-1 Ookayama, Meguro, Tokyo
Tel
03-5734-3808
hitorinri@jim.titech.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
| 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
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 | 03 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 21 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 21 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054955
