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

Not Applicable

Recruiting

• Conditions: Chronic hepatitis, unspecified,

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

Brief Summary

This study is an single-arm, Multi center, prospective Interventional study to evaluate the effect of oral nutritional supplement on improving malnutrition and sarcopenia  when given one to Three servings per day, prescribed by PI according to the patient protein requirement, based on individual body weight for 3 months in 76 patients (≥ 18 years to ≤65 years) with Chronic Liver disease (CLD) patients that will be conducted in India. The primary endpoint will be to evaluate the impact of oral nutritional supplement on liver and nutritional status from baseline to approximately 3 months in malnourished CLD patients and the secondary endpoint will be to evaluate the impact of oral nutritional supplement, from baseline to approximately 3 months in malnourished CLD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-15
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Age ≥ 18 years to ≤ 65 years’ 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.
• No clinical evidence of infection, comorbidities diabetes mellitus.
• Alcoholic patients who have been abstinent for at least 3 months.
• No sepsis for less than 4 weeks 7.
• Hepatocellular carcinoma (HCC) patients can be included.
• Patients with creatinine less than 1.5mg/dl 10.
• Patients who are waiting for liver transplant.

Exclusion Criteria

• Allergy or contraindications to protein, milk, nuts, or any of the ingredients of the nutritional supplement.
• All cancers patients except Hepatocellular carcinoma to be excluded.
• Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.
• Patients not able to tolerate the oral nutritional supplements (ONS).
• Pregnant and lactating women.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (4)

Aditya Multispecialty Hospitals; 🇮🇳 Guntur, ANDHRA PRADESH, India

Gleneagles Global Health City; 🇮🇳 Chennai, TAMIL NADU, India

Gleneagles Global Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Rela Hospitals; 🇮🇳 Chennai, TAMIL NADU, India

Aditya Multispecialty Hospitals

🇮🇳Guntur, ANDHRA PRADESH, India

Dr Nikileshwar Yandamuri

Principal investigator

researchaditya26@gmail.com