UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054474 |
|---|---|
| Receipt number | R000062156 |
| Scientific Title | Effects of continuous protein supplementation on liver and kidney function |
| Date of disclosure of the study information | 2024/06/24 |
| Last modified on | 2025/05/26 09:40:51 |
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Basic information
Public title
Effects of continuous protein supplementation on liver and kidney function
Acronym
Effects of protein supplementation on liver and kidney
Scientific Title
Effects of continuous protein supplementation on liver and kidney function
Scientific Title:Acronym
Effects of protein supplementation on liver and kidney
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of long-term continuous protein supplementation on liver and kidney function
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Asparate aminotransferase(AST/GOT)
Alanine aminotransferase(ALT/GPT)
gamma-Glutamyltransferase(gamma-GT)
Alkaline phosphatase (ALP)
Total protein (TP)
Albumin(Alb)
Total bilirubin(T-Bil)
Lactate dehydrogenase(LDH)
Amylase(AMY)
Creatinine
Urea nitrogen(UN)
Key secondary outcomes
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
| 21 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy male adult
Key exclusion criteria
female
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports, Faculty of Health Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
TEL
0252574586
akiko-sato@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Sato |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Sports, Faculty of Health Sciences
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
TEL
0252574586
Homepage URL
akiko-sato@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata Prefecture
Tel
0252574455
rinri@nuhw.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
| 2024 | Year | 06 | 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
17
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
| 2024 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Liver and kidney function will be checked by blood tests in the group that takes protein supplements on a daily basis (PRO group) and the group that does not take protein supplements (CON group). The PRO group will be asked to keep a record of their protein supplement intake for a certain period of time in order to determine the exact amount of protein supplements consumed. No dietary or lifestyle restrictions will be imposed on either group. After the PRO group has completed the period of recording, a dietary survey using the food frequency survey method and blood sampling will be conducted at the same time for analysis.
Management information
Registered date
| 2024 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062156
