Evaluation of the Hepatoprotective Effects of a Nutritional Supplement in Patients With Liver Disease Secondary to Chronic Hepatitis C Virus Infection (RESQUETI Study).

University of Guadalajara26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Liver Disease Chronic HEPATITIS C VIRUS CHRONIC INFECTION

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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. \- Exclusion Criteria: * 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.

Locations (2)

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

RECRUITING

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

RECRUITING

Outcomes

Primary Outcomes

Liver function measurements

Serum concentrations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST)

Time frame: From enrollment to the end of treatment at 12 weeks

Quality of life (CLDQ)

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.

Time frame: From enrollment to the end of treatment at 12 weeks

Frailty

Physical frailty assessed using the Liver Frailty Index (LFI)

Time frame: 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).

Secondary Outcomes

Pro-inflammatory cytokines

Serum concentrations of pro-inflammatory cytokines (IL-1β, TNF-α, TGF-β)

Time frame: From enrollment to the end of treatment at 12 weeks

Antioxidant activity

Serum concentrations of antioxidant enzymes superoxide dismutase (SOD) and catalase (CAT)

Time frame: From enrollment to the end of treatment at 12 weeks

Evaluation of the Hepatoprotective Effects of a Nutritional Supplement in Patients With Liver Disease Secondary to Chronic Hepatitis C Virus Infection (RESQUETI Study).

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts