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

ConditionsLiver Disease ChronicHEPATITIS C VIRUS CHRONIC INFECTION
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-69
SponsorUniversity of Guadalajara

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • resveratrol, quercetin, taurine, whey protein, and inulin

    Dietary supplement

    powdered supplement containing resveratrol, quercetin, taurine, whey protein, and inulin

  • whey protein

    Dietary supplement

    powdered supplement containing whey protein

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: SuplementExperimental treatment 1 intervention
Group B: Whey proteinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

1

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
2

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

Other outcomes

Sponsors and contacts

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University of Guadalajara

Lead sponsor

Hospital Civil de Guadalajara

Collaborator

Centro Universitario de Ciencias de la Salud, Mexico

Collaborator

Source ClinicalTrials.gov
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