跳至主要内容
临床试验/NCT07299110
NCT07299110招募中不适用

Effect of Whey Protein Versus Egg Albumen Protein Challenge on Blood Ammonia Level in Patients of Decompensated Ethanol Related Cirrhosis.

Institute of Liver and Biliary Sciences, India2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月12日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
To compare the effects of whey protein versus egg albumen protein oral challenge in blood ammonia level after 3 hours in decompensated ethanol related cirrhosis.

研究概览

简要总结

In cirrhosis, altered nitrogen metabolism and reduced hepatic clearance of ammonia contribute to the development of Minimal Hepatic Encephalopathy (MHE)-a subclinical but functionally debilitating condition. While adequate protein intake is essential to prevent sarcopenia in cirrhotic patients, the type of protein consumed can significantly influence postprandial ammonia generation, thereby affecting neurocognitive status.

This study investigates the differential ammoniagenic potential of two commonly used high-protein nutritional supplements-Whey protein, which is rich in branched-chain amino acids (BCAAs) and rapidly absorbed, and egg albumen protein, which is slower digesting and higher in aromatic amino acids (AAAs), potentially more ammoniagenic.

In a crossover pilot design, 50 patients with decompensated ethanol-related cirrhosis will undergo two separate standardized protein challenges with 30g of each protein, spaced 24 hours apart. Venous ammonia levels and MHE parameters (via PHES/Stroop test) will be recorded pre- and 3 hours post-challenge.

The primary objective is to compare the change in blood ammonia between the two protein types. Secondary objectives include assessing MHE induction or worsening, and analysing the correlation between ammonia changes and cognitive decline.

By directly comparing the metabolic and neurocognitive response to distinct protein sources, this study will help inform safer dietary practices and refine nutritional supplementation in cirrhosis, especially for those at risk of hepatic encephalopathy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Known or newly diagnosed (clinical, imaging) case of decompensated ethanol related cirrhosis patients.
  • Age (18-70 years).
  • Informed consent to participate in the study.

排除标准

  • History of overt HE (West Haven grade II or more).
  • Last Intake <1.5 months.
  • CKD (creatinine >1.5 mg/dL), active infection, GI bleeding in past 2 weeks.
  • Severe anaemia (Hb <7 g/dL) or hypoalbuminemia (<2.0 g/dL).
  • Known egg or dairy allergy.
  • Those on sedatives, antidepressant or anti-psychiatric medication.
  • Unable to understand the language or instructions.
  • Hepatocellular Carcinoma.
  • Receiving rifaximin or lactulose.
  • Diarrhea, SIBO or malabsorptive syndrome.

结局指标

主要结局

To compare the effects of whey protein versus egg albumen protein oral challenge in blood ammonia level after 3 hours in decompensated ethanol related cirrhosis.

时间窗: 24 hours

次要结局

  • To determine the prevalence of minimal hepatic encephalopathy (MHE).(24 hours)
  • To compare the prevalence of MHE in 24 hours following whey protein versus egg albumen protein challenge.(24 hours)
  • Initial lab parameters that predict protein challenge induced MHE.(24 hours)
  • Number of participants with treatment related adverse effects accessed by CTCAE v4.0(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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