UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050373 |
|---|---|
| Receipt number | R000057356 |
| Scientific Title | Protein rich food RCT research |
| Date of disclosure of the study information | 2023/02/24 |
| Last modified on | 2024/02/18 09:22:04 |
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Basic information
Public title
Protein rich food research (PRFR)
Acronym
PRFR
Scientific Title
Protein rich food RCT research
Scientific Title:Acronym
PRFR study
Region
| Japan |
Condition
Condition
healthy elders
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Improving the health status of healthy elderly people by consuming protein-rich foods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive function
Key secondary outcomes
Locomotor function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Protein-rich food A
Interventions/Control_2
Protein-rich food B
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
| 65 | years-old | <= |
Age-upper limit
| 92 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy elders
Key exclusion criteria
Dementia
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Hisatsune |
Organization
UTokyo
Division name
GSFS
Zip code
2778562
Address
5-1-5 Kashiwanoha, Kashiwa
TEL
0471363632
hisatsune@edu.k.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuhiro |
| Middle name | |
| Last name | Hisatsune |
Organization
UTokyo
Division name
GSFS
Zip code
2778562
Address
5-1-5 Kashiwanoha, Kashiwa
TEL
0471363632
Homepage URL
hisatsune@edu.k.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Tatsuhiro Hisatsune
Funding Source
Organization
UTokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
NH Foods Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
GSFS, UTokyo
Address
5-1-5 KAshiwanoha, Kashiwa
Tel
0471363632
hisatsune@edu.k.u-tokyo.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 | 02 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 02 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057356
