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

March 17, 2026 updated by: University of Guadalajara

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).

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Recruiting
        • Hospital Civil de Guadalajara Fray Antonio Alcalde
        • Contact:
      • Guadalajara, Jalisco, Mexico
        • Recruiting
        • Hospital Civil de Guadalajara Fray Antonio Alcalde
        • Contact:
          • Roberto, Doctor in Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Whey protein
Dietary supplement: whey protein
powdered supplement containing whey protein
Experimental: Suplement
powdered supplement containing resveratrol, quercetin, taurine, insulin, and whey protein.
Dietary supplement: resveratrol, quercetin, taurine, whey protein, and inulin
powdered supplement containing resveratrol, quercetin, taurine, whey protein, and inulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver function measurements
Time Frame: From enrollment to the end of treatment at 12 weeks
Serum concentrations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
From enrollment to the end of treatment at 12 weeks
Quality of life (CLDQ)
Time Frame: 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.
From enrollment to the end of treatment at 12 weeks
Frailty
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).
Physical frailty assessed using the Liver Frailty Index (LFI)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pro-inflammatory cytokines
Time Frame: From enrollment to the end of treatment at 12 weeks
Serum concentrations of pro-inflammatory cytokines (IL-1β, TNF-α, TGF-β)
From enrollment to the end of treatment at 12 weeks
Antioxidant activity
Time Frame: From enrollment to the end of treatment at 12 weeks
Serum concentrations of antioxidant enzymes superoxide dismutase (SOD) and catalase (CAT)
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guadalajara

Collaborators

Hospital Civil de Guadalajara
Centro Universitario de Ciencias de la Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI 183/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It might be considered.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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