UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049750 |
|---|---|
| Receipt number | R000056313 |
| Scientific Title | Effect of protein-containing food intake on gastric emptying and appetite |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2022/12/12 12:11:08 |
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Basic information
Public title
Effect of protein-loaded food intake at breakfast on nutritional status
Acronym
Protein-loaded foods and nutritional status
Scientific Title
Effect of protein-containing food intake on gastric emptying and appetite
Scientific Title:Acronym
Protein-loaded foods and nutritional status
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of protein supplementation at breakfast on nutritional intake status in young adults aged 20-40 years and aged 65 years and older
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nutritional intake status
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of protein-loaded foods at breakfast
Interventions/Control_2
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
Men and women aged 20 to 40 years, men and women aged 65 years and older
Key exclusion criteria
1) Patients with diabetes mellitus or renal disorder requiring dietary restrictions, 2) Patients taking antipsychotics or hormonal agents that may affect appetite
Target sample size
40
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-ku, Tokyo
TEL
03-5734-2904
takahashi.m.bp@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Fujihira |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama, Meguro-ku, Tokyo
TEL
03-5734-2904
Homepage URL
fujihira.k.ac@m.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Tokyo Institute of Technology
Address
2-12-1, Ookayama, Meguro-ku, 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
| 2023 | Year | 04 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | 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
| 2022 | Year | 12 | Month | 12 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056313
