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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048117
Receipt No. 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 2022/06/21

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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
Email 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
Email nagayama.chihiro@hc-sys.jp

Sponsor
Institute Healthcare Systems Co., Ltd.
Institute
Department

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
Email 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
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
2022 Year 06 Month 16 Day
Date of IRB
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 06 Month 21 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054840

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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