A multi centre, single-arm, prospective interventional study to evaluate the therapeutic effect of oral nutritional supplement on improving malnutrition and sarcopenia in chronic liver disease (CLD) patients.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- a)Gamma glutamyl transpeptidase (GGT),
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥ 18 years to ≤ 65 years’ adults (male or female diagnosed with chronic liver disease) with clinically diagnosed chronic liver disease
- •Malnutrition screening tool i.e., royal free hospital malnutrition tool (See below for details)
- •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
- •Hepatocellular carcinoma (HCC) patients can be included.
- •Patients with creatinine less than 1.5mg/dl
- •Patients who are waiting for liver transplant.
排除标准
- •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.
结局指标
主要结局
a)Gamma glutamyl transpeptidase (GGT),
时间窗: 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
时间窗: 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:
时间窗: 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:
时间窗: 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
时间窗: 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),
时间窗: 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)
次要结局
- 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.)