UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038473 |
|---|---|
| Receipt number | R000043843 |
| Scientific Title | Effect of Protein intakes on Nutritional status among Japanese young women - Interventional study |
| Date of disclosure of the study information | 2019/11/02 |
| Last modified on | 2022/11/22 17:35:53 |
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Basic information
Public title
Effect of Protein intakes on Nutritional status among Japanese young women - Interventional study
Acronym
Protein Interventional study on Nutritional status among Japanese young women (PIN Japanese Study)
Scientific Title
Effect of Protein intakes on Nutritional status among Japanese young women - Interventional study
Scientific Title:Acronym
Protein Interventional study on Nutritional status among Japanese young women (PIN Japanese Study)
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is the effect of protein intake on protein and iron nutritional status among Japanese young women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ferritin
Key secondary outcomes
Albumin, Pre-albumin, Transferrin, Hepcidin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Participants will have a meal containing EAR level protein for 1 week, and then they will have a meal containing 2xEAR level protein for 1 week
Interventions/Control_2
Participants will have a meal containing RDA level protein for 1 week, and then they will have a meal containing 2xEAR level protein for 1 week
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy college and graduated students
Key exclusion criteria
No Food Allergy
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Azumi |
| Middle name | |
| Last name | Hida |
Organization
Tokyo University of Agriculture
Division name
Department of Nutritional Science
Zip code
156-8502
Address
1-1-1, Sakuragaoka, Setagaya, Tokyo, 156-8502 Japan
TEL
+81-(0)3-5477-2378
a3hida@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Azumi |
| Middle name | |
| Last name | Hida |
Organization
Tokyo University of Agriculture
Division name
Department of Nutritional Science
Zip code
156-8502
Address
1-1-1, Sakuragaoka, Setagaya, Tokyo, 156-8502 Japan
TEL
+81-(0)3-5477-2378
Homepage URL
a3hida@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Agriculture
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Agriculture, IRB
Address
1-1-1, Sakuragaoka, Setagaya, Tokyo, 156-8502 Japan
Tel
+81-(0)3-5477-2532
nri@nodai.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
| 2019 | Year | 11 | Month | 02 | 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
6
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 02 | 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
| 2019 | Year | 11 | Month | 02 | Day |
Last modified on
| 2022 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043843
| 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 |
