UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059839 |
|---|---|
| Receipt number | R000066239 |
| Scientific Title | Evaluation of Amino Acid Intake Balance and Prognosis in Patients with Liver Cirrhosis Using an AI-Based Dietary Management App |
| Date of disclosure of the study information | 2025/11/21 |
| Last modified on | 2025/11/21 16:54:42 |
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Basic information
Public title
A study to Evaluate Amino Acid Intake Balance and Prognosis in Patients with Liver Cirrhosis Using an AI-Based Dietary Management App.
Acronym
A4C trial
Scientific Title
Evaluation of Amino Acid Intake Balance and Prognosis in Patients with Liver Cirrhosis Using an AI-Based Dietary Management App
Scientific Title:Acronym
A4C trial
Region
| Japan |
Condition
Condition
Hepatic cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the differences in amino acid intake between the improvement and non-improvement groups based on liver cirrhosis-related parameters.
Basic objectives2
Others
Basic objectives -Others
In liver cirrhosis, imbalances in amino acid metabolism are known to contribute to various complications. A decrease in branched-chain amino acids (BCAAs) and an increase in aromatic amino acids have been reported, and the efficacy of BCAA supplementation has been established. However, the relationship between dietary amino acid intake in daily life and clinical outcomes in patients with cirrhosis remains unclear. The aim of this study is to analyze amino acid intake and clinical outcomes in patients with liver cirrhosis using an AI-based meal planning application.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in amino acid intake between the improvement and non-improvement groups based on liver cirrhosis-related blood tests, muscle strength, questionnaires, and hepatic encephalopathy tests (Stroop test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A nutritional intervention with a guideline-based high-protein diet will be conducted in patients with liver cirrhosis using an AI-based dietary application. After a 3-month intervention period, a 3-month follow-up will be performed. Upon completion of the trial, differences in clinical outcomes and amino acid intake patterns will be analyzed.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals who have provided written informed consent to participate in the study
2. Males or females aged >=20 and <100 years at the time of consent
3. Individuals clinically diagnosed with liver cirrhosis
4. Individuals with serum albumin level <=4.0 g/dL
Key exclusion criteria
1. Individuals with a history of congenital amino acid metabolism disorders
2. Individuals currently taking amino acid preparations
3. Individuals who initiated or changed the dose of diuretics, synthetic disaccharides, or rifaximin within the past 6 months
4. Individuals who are pregnant or breastfeeding
5. Individuals currently undergoing treatment for malignancies other than hepatocellular carcinoma
6. Individuals with difficulty in oral intake
7. Individuals with disorders affecting digestion or absorption
8. Individuals with impaired renal function (eGFR < 60 mL/min/1.73 m2)
9. Individuals deemed unsuitable for study participation by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Kakazu |
Organization
National Kohnodai Medical Center, Japan Institute for Healthy Security
Division name
Department of Gastroenterology and Hepatology
Zip code
2728516
Address
1-7-1 Kohnodai, Ichikawa, Chiba
TEL
0473723501
kakazu.e@jihs.go.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Kakazu |
Organization
National Kohnodai Medical Center, Japan Institute for Healthy Security
Division name
Department of Gastroenterology and Hepatology
Zip code
2728516
Address
1-7-1 Kohnodai, Ichikawa, Chiba
TEL
0473723501
Homepage URL
kakazu.e@jihs.go.jp
Sponsor or person
Institute
Japan Institute for Healthy Security
Institute
Department
Personal name
Funding Source
Organization
Japan Institute for Healthy Security
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
Japan Institute for Healthy Security
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel
0332027181
kenkyu-shinsa@jihs.go.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
| 2025 | Year | 11 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066239
