Evaluation of the Hepatoprotective Effects of a Nutritional Supplement Containing Resveratrol, Quercetin, Taurine, Inulin, and Whey Protein on Biochemical, Molecular, and Clinical Markers in Patients With Liver Disease Secondary to Chronic Hepatitis C Virus Infection (RESQUETI Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Liver function measurements
研究概览
简要总结
The purpose of this clinical trial is to evaluate whether a nutritional supplement containing resveratrol, quercetin, taurine, inulin, and whey protein improves biochemical and molecular markers, as well as clinical outcomes, in patients with liver disease related to chronic hepatitis C infection.
The study will compare the investigational supplement with an active control (whey protein alone) to determine whether the combination formulation provides additional benefits on liver-related biomarkers and clinical assessment.
Participants will:
Take the investigational supplement or active control daily for 12 weeks.
Attend clinic visits every 4 weeks for laboratory testing and clinical evaluations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The Financial Institution is also blinded.
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with liver disease secondary to chronic hepatitis C virus infection who attend the outpatient Hepatitis Clinic of the Gastroenterology Department at Hospital Civil Fray Antonio Alcalde.
- •Child-Pugh score < 8 points. Age 18-69 years. Both sexes. Signed informed consent.
排除标准
- •Patients with alcohol consumption within the past 6 months. Patients with a history of acute-on-chronic liver failure (ACLF). Patients with persistent hepatic encephalopathy. Patients unable to perform frailty assessments. Patients with refractory ascites. Patients with a history of hepatorenal syndrome. Patients with a history of hepatopulmonary syndrome. Patients with chronic kidney disease. Patients with autoimmune diseases. Patients with any type of cancer. Patients with dementia or other significant mental illnesses. Use of protein supplements or probiotics.
结局指标
主要结局
Liver function measurements
时间窗: From enrollment to the end of treatment at 12 weeks
Serum concentrations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Quality of life (CLDQ)
时间窗: From enrollment to the end of treatment at 12 weeks
Quality of life was assessed using the Chronic Liver Disease Questionnaire (CLDQ), which evaluates domains such as fatigue, worry, systemic symptoms, abdominal symptoms, activity, and overall assessment. The maximum score is 7, indicating better quality of life.
Frailty
时间窗: The LFI includes grip strength, timed chair stands, and balance testing. Frailty classifications were determined using previously established LFI cutoffs: robust (LFI < 3.2), prefrail (LFI 3.2-4.4), and frail (LFI ≥ 4.5).
Physical frailty assessed using the Liver Frailty Index (LFI)
次要结局
- Pro-inflammatory cytokines(From enrollment to the end of treatment at 12 weeks)
- Antioxidant activity(From enrollment to the end of treatment at 12 weeks)