UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048117 |
|---|---|
| Receipt number | R000054840 |
| Scientific Title | Study on the improvement effect of amino acids containing supplement on kidney function |
| Date of disclosure of the study information | 2022/06/21 |
| Last modified on | 2022/12/20 11:58:08 |
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Basic information
Public title
Study on the improvement effect of amino acids containing supplement on kidney function
Acronym
Study on the improvement effect of amino acids containing supplement on kidney function
Scientific Title
Study on the improvement effect of amino acids containing supplement on kidney function
Scientific Title:Acronym
Study on the improvement effect of amino acids containing supplement on kidney function
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the improvement effect of 12-week continuous ingestion of amino acids containing supplement on kidney function in 20 to 64 years old adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimated glomerular filtration rate cystatin C (eGFRcys)
Estimated glomerular filtration rate creatinine (eGFRcrea)
Key secondary outcomes
Proteinuria
Urinary glucose
Hematuria
Urinary creatinine
Urinary albumin
Subjective fatigue and sleeping
Sleep habit
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest 2 tablets of the test food (amino acids containing supplement) each after breakfast and dinner daily for 12 weeks
Interventions/Control_2
Ingest 2 tablets of the placebo food (dextrin) each after breakfast and dinner daily for 12 weeks
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Persons who provide written informed consent
2. Healthy Japanese who are 20 years old or more and under 64 years old
3. Persons with eGFRcys values in the bottom 40 at screening
Key exclusion criteria
1. Persons who have any chronic illnesses with medication and who have any serious disease histories
2. Persons who are classified in moderate risk or higher (orange or red) of CKD stages
3. Persons who are classified in G3a of GFR categories and under 40 years old
4. Persons who are classified in G1 or G2 of GFR categories, and present with mild proteinuria(0.15~0.49 g/gCr)and hematuria
5. Persons who have a history of CKD diagnosed by markers of kidney damage (albuminuria (AER more thatn 30mg/24 hours; ACR more than 30mg/gCr), urine sediment abnormalities, electrolyte and other abnormalities due to tubular disorders, abnormalities detected by histology, structural abnormalities detected by imaging, or history of kidney transplantation)
6. Persons who have any allergies to the ingredients used in the test food
7. Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect renal function
8. Persons who have participated in other tests within the past one month before the start of test, or those who intend to participate in another exam after consenting to the exam
9. Persons who were judged as inappropriate for study participant by the principal investigator
10. Persons who are breast-feeding, pregnant and planning or wishing to become pregnant during the study period
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Nagayama |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
nagayama.chihiro@hc-sys.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Nagayama |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
nagayama.chihiro@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Igakukobo Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2022 | Year | 06 | Month | 21 | 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
40
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054840
| 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 |
