HEPATITIS C VIRUS CHRONIC INFECTION, Liver Disease Chronic
Conditions
Keywords
liver disease chronic, hcv, resveratrol, quercetin, taurine, inulin, frailty, whey protein
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTresveratrol, quercetin, taurine, whey protein, and inulin
powdered supplement containing resveratrol, quercetin, taurine, whey protein, and inulin
DIETARY_SUPPLEMENTwhey protein
powdered supplement containing whey protein
Sponsors
University of Guadalajara
Hospital Civil de Guadalajara
Centro Universitario de Ciencias de la Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The Financial Institution is also blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver function measurements | From enrollment to the end of treatment at 12 weeks | Serum concentrations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) |
| Quality of life (CLDQ) | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pro-inflammatory cytokines | From enrollment to the end of treatment at 12 weeks | Serum concentrations of pro-inflammatory cytokines (IL-1β, TNF-α, TGF-β) |
| Antioxidant activity | From enrollment to the end of treatment at 12 weeks | Serum concentrations of antioxidant enzymes superoxide dismutase (SOD) and catalase (CAT) |
Countries
Mexico
Contacts
CONTACTJuan Roberto Rodriguez-Echevarria, PhD
Outcome results
None listed