The effect of a diet based on vegetable and dairy protein in patients with liver cirrhosis

The effect of a diet based on vegetable and dairy protein on biochemical and functional indicators of sarcopenia in patients with liver cirrhosis: a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220426054667N2

Enrollment

Registered

2023-06-08

Start date

2023-06-21

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

liver cirrhosis. Other and unspecified cirrhosis of liver

Interventions

Intervention 1: Intervention group: A diet based on vegetable and dairy protein. Based on the latest guidelines, in this diet, energy will be calculated 1/3 times REE (using the Harris-Benedict equati

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Having liver cirrhosis with a doctor's diagnosis for at least 6 months Age range from 30 to 60 years Willingness to participate in the study

Exclusion criteria

Exclusion criteria: MELD score greater than 18 or Child-Pugh Class C Active gastrointestinal bleeding Serum creatinine above 1.5 mg/dl during the last month Alcohol and tobacco consumption during the last 6 months Pregnancy and lactation Suffering from diabetes, pulmonary diseases, psychological disorders, hepatocellular carcinoma and other cancers, heart failure, acute viral hepatitis, cholestatic cirrhosis, autoimmune cirrhosis, other autoimmune diseases, hyperuricemia, musculoskeletal diseases Taking corticosteroids and immunosuppressive medications

Design outcomes

Primary

Measure	Time frame
Myostatin. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: ELISA.;4-metre Gait Speed Test. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: chronometer.;Five Times Sit to Stand Test. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Chronometer.;Handgrip strength. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Dynamometer.;Weight. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Digital scale.;Body Mass Index (BMI). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Weight (Kg)/height(m)2.;Middle Arm Circumference (MAC). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Tape.;Triceps skin fold (TSF). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Caliper.;Middle Arm Muscle Circumference (MAMC). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: MAMC = MAC – (3.1416 × TSF).;Ammonia. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Biochemical kit.;Total bilirubin. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Photometric.;Prothrombin time (PT). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Biochemical kit.;Model for End-Stage Liver Disease. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Formula: 9.57 × loge (creatinine) + 3.78 × loge (total bilirubin) + 11.2 × loge (INR) + 6.43.;Serum creatinine. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Jaafe.;International Normalized Ratio (INR). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Formula: INR = [patient PT (s)/MNPT (s)] ISI.;Albumin. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Special kit.;Total protein. Timepoint: Baseline and	—

Measure

Time frame

Myostatin. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: ELISA.;4-metre Gait Speed Test. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: chronometer.;Five Times Sit to Stand Test. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Chronometer.;Handgrip strength. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Dynamometer.;Weight. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Digital scale.;Body Mass Index (BMI). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Weight (Kg)/height(m)2.;Middle Arm Circumference (MAC). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Tape.;Triceps skin fold (TSF). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Caliper.;Middle Arm Muscle Circumference (MAMC). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: MAMC = MAC – (3.1416 × TSF).;Ammonia. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Biochemical kit.;Total bilirubin. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Photometric.;Prothrombin time (PT). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Biochemical kit.;Model for End-Stage Liver Disease. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Formula: 9.57 × loge (creatinine) + 3.78 × loge (total bilirubin) + 11.2 × loge (INR) + 6.43.;Serum creatinine. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Jaafe.;International Normalized Ratio (INR). Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Formula: INR = [patient PT (s)/MNPT (s)] ISI.;Albumin. Timepoint: Baseline and after 12 weeks of intervention. Method of measurement: Special kit.;Total protein. Timepoint: Baseline and

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSomayyeh Asghari

Tehran University of Medical Sciences

asghari.nut@gmail.com0098 21 889900285

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jul 17, 2026