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NCT Number: NCT07487623

Evaluation of the Hepatoprotective Effects of a Nutritional Supplement 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.

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Key information

Conditions

Liver Disease Chronic Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Frailty HEPATITIS C VIRUS CHRONIC INFECTION Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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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.

Treatment and study plan

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

Primary outcomes

  1. 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)

  2. 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.

  3. 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)

Secondary outcomes

  1. 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)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Roberto Rodriguez-Echevarria, PhD

CONTACT

[email protected]

+52 33 18 23 13 10

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Collaborators

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

Registry information

Official study title

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).

Acronym: RESQUETI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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