UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036487
Receipt number R000040853
Scientific Title Study of protein metabolism and muscle mass improvement by switching to BCAA-enriched nutrient mixture in cirrhotic patients with BCAA granules refractory hypoalbuminemia
Date of disclosure of the study information 2019/04/12
Last modified on 2019/10/13 13:19:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

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

Acronym

Protein metabolism and muscle mass improvement in liver cirrhosis patients with BCAA-enriched nutrient mixture

Scientific Title

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

Scientific Title:Acronym

Protein metabolism and muscle mass improvement in liver cirrhosis patients with BCAA-enriched nutrient mixture

Region

Japan


Condition

Condition

Liver cirrhosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prospectively investigate the effect of nutritional intervention by BCAA-enriched nutrient mixture in BCAA granules formulation refractory cirrhotic patients on hypoalbuminemia, PEM and muscle mass.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Changes of albumin value after 12 weeks

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

BCAA-enriched nutrient mixture group

Aminoleban EN, one after eating breakfast and one at sleep for 48 weeks

Interventions/Control_2

BCAA Granules Formulation Group

BCAA Granules, after every meal (3 packs/day) for 48 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


Not applicable

Gender

Male and Female

Key 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.

Key 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

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Hirayuki
Middle name
Last name Enomoto

Organization

Hyogo college of medicine

Division name

Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine

Zip code

6638501

Address

1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, japan

TEL

0798-45-6472

Email

kantan@hyo-med.ac.jp


Public contact

Name of contact person

1st name Yoshiyuki
Middle name
Last name Sakai

Organization

Hyogo college of medicine

Division name

Department of Hepatobiliary and Pancreatic disease, Department of Internal Medicine

Zip code

6638187

Address

1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, japan

TEL

0798-45-6472

Homepage URL


Email

kantan@hyo-med.ac.jp


Sponsor or person

Institute

Hyogo college of medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo college of medicine

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

Hyogo college of medicine

Address

1-1, Mukogawacho, Nishinomiyashi, Hyogo, 663-8501, japan

Tel

0798-45-6472

Email

kantan@hyo-med.ac.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

2019 Year 04 Month 12 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

Enrolling by invitation

Date of protocol fixation

2019 Year 04 Month 01 Day

Date of IRB

2019 Year 04 Month 12 Day

Anticipated trial start date

2019 Year 04 Month 12 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 12 Day

Last modified on

2019 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040853


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name