Study of protein metabolism and muscle mass improvement by switching to BCAA-enriched nutrient mixture in cirrhotic patients with BCAA granules refractory hypoalbuminemia

Study of protein metabolism and muscle mass improvement by switching to BCAA-enriched nutrient mixture in cirrhotic patients with BCAA granules refractory hypoalbuminemia - Protein metabolism and muscle mass improvement in liver cirrhosis patients with BCAA-enriched nutrient mixture

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036487

Enrollment

Registered

2019-04-12

Start date

2019-04-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis

Interventions

BCAA-enriched nutrient mixture group Aminoleban EN, one after eating breakfast and one at sleep for 48 weeks BCAA Granules Formulation Group BCAA Granules, after every meal (3 packs/day) for 48

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Cirrhotic patients with hypoalbuminemia (<3.5g/dl) despite taking more than two months of BCAA granules formulation therapy. 2. Patients with hepatic encephalopathy. 3. Patients over 20 years of age. 4. Cirrhotic patients who are expected to take a certain amount of food after nutritional guidance. 5. Previous anti-viral therapies and other nutritional therapies for cirrhosis are not limited. 6. Patients with written informed consent by their free will after full explanation of this trial.

Exclusion criteria

Exclusion criteria: 1.Patients receiving albumin preparations more than once per week 2. Patients who are pointed out to have HCC or those receiving HCC therapy within half a year 3. Patients with poor control of glucose metabolism (HbA1c > 8%) 4. Patients with severe renal dyfunction (serum creatinine > 2.0 or hemodialysis patients) 5. Patients with congenital amino acid metabolism 6. Patients with a history of hypersensitivity to Aminoleban EN 7. Patients with allergies to milk 8. Patients with serious complications 9. Patients who are judged to be ineligible for the study subjects by investigators

Design outcomes

Primary

Measure	Time frame
Changes of albumin value after 12 weeks	—

Secondary

Measure	Time frame
Muscle mass and body measurement by bioimpedance analysis Evaluation for energy metabolism using indirect calorimetry. Evaluation for protein metabolism Laboratory parameters and physical examinations These will be tested at baseline, 12, 24, 36 and 48 weeks	—

Countries

Japan

Contacts

Public ContactYoshiyuki Sakai

Hyogo college of medicine Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine

kantan@hyo-med.ac.jp0798-45-6472

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026