Tokyo, Nov. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059839) titled 'A study to Evaluate Amino Acid Intake Balance and Prognosis in Patients with Liver Cirrhosis Using an AI-Based Dietary Management App' on Nov. 21.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Japan Institute for Healthy Security

Condition: Condition - Hepatic cirrhosis Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 20 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 Size - 60

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066239

Disclaimer: Curated by HT Syndication.