UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037667 |
|---|---|
| Receipt number | R000042959 |
| Scientific Title | Effect of the High Protein intake on Iron metabolism among Japanese people in Kenya: Intervention study |
| Date of disclosure of the study information | 2019/08/12 |
| Last modified on | 2023/08/15 11:51:44 |
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Basic information
Public title
Effect of the High Protein intake on Iron metabolism among Japanese people in Kenya: Intervention study
Acronym
PIJaK study
Scientific Title
Effect of the High Protein intake on Iron metabolism among Japanese people in Kenya: Intervention study
Scientific Title:Acronym
PIJaK study
Region
| Japan | Africa |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Kenya, iron deficiency anemia is one of the health issue. Increasing iron intake is recommended to prevent anemia, but it is also important to have a protein-rich diet. In this study, we investigate the possibility of iron deficiency anemia prevention in terms of iron nutritional status when taking protein in addition to the daily diet of Kenya.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
after 1 week.
serum iron, Ferritin
Key secondary outcomes
Total protein, Albumin, Pre-albumin Transferrin, CRP, TIBC, WBC, RBC, Hemoglobin, Hematocrit, MCV, MCH, MCHC,platelet, AST, ALT, TG, Total cholesterol, LDL-cholesterol, HDL-cholesterol, glucose, HbA1c
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
In addition to meals at homestay, take a protein-rich food (equivalent to 32 g protein = 8 g in the morning + 24 g in the evening) every day for one week every day to avoid changing the habitual diet Family content.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy person
Key exclusion criteria
Food allergies
Target sample size
10
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, JAPAN
TEL
03-5477-2378
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, JAPAN
TEL
03-5477-2378
Homepage URL
a3hida@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
MAFF (Japan)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nodai Research Institute, Tokyo University of Agriculture
Address
1-1-1, Sakuragaoka, Setagaya, Tokyo, JAPAN
Tel
03-5477-2532
a3hida@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 | 08 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 06 | 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
| 2019 | Year | 08 | Month | 12 | Day |
Last modified on
| 2023 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042959
| Research Plan | |
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| 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 |
