UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053391 |
|---|---|
| Receipt number | R000060934 |
| Scientific Title | Simple formula for estimating protein intake based on the relationship between the intake estimated from 24-hour urine collection method and doubly-labeled water method, and personal attributes |
| Date of disclosure of the study information | 2024/01/18 |
| Last modified on | 2025/01/17 20:02:54 |
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Basic information
Public title
Simple formula for estimating protein intake based on the relationship between the intake estimated from 24-hour urine collection method and doubly-labeled water method, and personal attributes
Acronym
Simple formula for estimating protein intake based on the relationship between the intake estimated from 24-hour urine collection method and doubly-labeled water method, and personal attributes
Scientific Title
Simple formula for estimating protein intake based on the relationship between the intake estimated from 24-hour urine collection method and doubly-labeled water method, and personal attributes
Scientific Title:Acronym
Simple formula for estimating protein intake based on the relationship between the intake estimated from 24-hour urine collection method and doubly-labeled water method, and personal attributes
Region
| Japan |
Condition
Condition
Formula for estimating protein intake
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an estimation formula to easily and accurately grasp an individual's protein intake
Basic objectives2
Others
Basic objectives -Others
Factors related to protein intake estimation and their contributions
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
magnitude of the correlation between protein intake calculated from urine analysis and estimation formula
Key secondary outcomes
age, sex, height, weight, body composition, medical examination results, urine analysis, questionnaire, food intake frequency survey, physical strength, skin, number of steps
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Permanent employee of Meiji Co., Ltd.
Those who can come to the Meiji Innovation Center at least once every two weeks.
Those who have the ability to consent (the ability to understand the content, significance, risks, etc. of the research, and decide whether or not to participate), read the informed consent document, asked any questions, and fully understood the research content and voluntarily agreed to participate in writing.
Key exclusion criteria
1. Those who have not had a health checkup within the past year
2. Those who were instructed to undergo a retest for kidney function or liver function in the most recent health checkup, but have not yet undergone the retest or are required to receive treatment after the retest
3. Those who are taking drugs that promote the excretion of nutrients that serve as an energy source
4. Those who have been diagnosed with overactive bladder
5. Those who are pregnant or breastfeeding
6. Those who are allergic to wheat, eggs, milk, soybeans, or almonds
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Miyachi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa-city, Saitama 359-1192, Japan
TEL
04-2947-7313
miyachim@waseda.jp
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Tagawa |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
042-632-5846
Homepage URL
ryouichi.tagawa@meiji.com
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings Co., Ltd.
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institutes of Biomedical Innovation, Health and Nutrition
Meiji Holdings Co., Ltd.
Meiji Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee on Research with Human Subjects
Address
1-104 Totsukamachi, Shinjuku-ku, Tokyo 169-8050 Japan
Tel
03-5272-1639
rinri@list.waseda.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
明治イノベーションセンター（東京都） / Meiji Innovation Center (Tokyo)
早稲田大学 スポーツ科学学術院 / Faculty of Sport Sciences, Waseda University (Saitama)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 18 | 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 | 10 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will evaluate the correlation between protein intake calculated from urine analysis and estimation formula.
Management information
Registered date
| 2024 | Year | 01 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060934
