Effect of Oral nutritional supplement on improving Malnourishment patients in Chronic liver disease (CLD) patients

Phase 4

• Conditions: Health Condition 1: K739- Chronic hepatitis, unspecified

• Registration Number: CTRI/2023/03/050644
• Lead Sponsor: Dr Reddys Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age >= 18 years to <= 65 yearsâ?? adults (male or female diagnosed with chronic liver disease) with clinically diagnosed chronic liver disease

2. Malnutrition screening tool i.e., royal free hospital malnutrition tool (See below for details)

3. No gastrointestinal bleeding for at least 4 weeks.

4. No clinical evidence of infection, comorbidities diabetes mellitus.

5. Alcoholic patients who have been abstinent for at least 3 months.

6. No sepsis for less than 4 weeks

7. Hepatocellular carcinoma (HCC) patients can be included.

8. Hepatic Encephalopathy (HE) less than grade three

9. Patients with creatinine less than 1.5mg/dl

10. Patients who are waiting for liver transplant.

Exclusion Criteria

1. Allergy or contraindications to protein, milk, nuts, or any of the ingredients of the nutritional supplement.

2. All cancers patients except Hepatocellular carcinoma to be excluded.

3. Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.

4. Patients not able to tolerate the oral nutritional supplements (ONS).

5. Pregnant and lactating women.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ï?· Change in liver status from baseline, and at the end of treatment, at approximately 3 months as indicated by: <br/ ><br>ï?§ Change in MELD-Na <br/ ><br>ï?§ Change in serum albumin <br/ ><br>ï?§ Change in liver function biomarkers: <br/ ><br>a)Gamma glutamyl transpeptidase (GGT), <br/ ><br>b)Aspartate transaminase (AST),Timepoint: Screening/Basline Day 0(Visit 1), <br/ ><br>Telephonic Follow up Week 4 (Visit 2), <br/ ><br>Telephonic Follow up Week 8 (Visit 3) <br/ ><br>End of study Week 12 (Visit 4)

Secondary Outcome Measures

Name	Time	Method
ï?· Changes in body composition particularly in fat and muscle mass and Sarcopenia, as assessed by bioelectrical impedance analysis (BIA) and DEXA Scan from baseline to approximately 3 months. <br/ ><br>ï?· Change in Serum creatinine, international normalized ratio (INR), serum sodium, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, serum globulin, total bilirubin from baseline to approximately 3 months. <br/ ><br>ï?· Change in plasma glucose and insulin estimated by a combined measure of homeostatic model assessment (HOMA) from baseline to 3 months. <br/ ><br>ï?· Change in quality-of-life indicators as assessed by SF-36, Chronic liver disease questionnaire (CLDQ) and handgrip strength from baseline to approximately 3 months.Timepoint: Screening/Basline Day 0(Visit 1), <br/ ><br>Telephonic Follow up Week 4 (Visit 2), <br/ ><br>Telephonic Follow up Week 8 (Visit 3) <br/ ><br>End of study Week 12 (Visit 4)