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

NCT07487623 | Recruiting

• 1 other identifier: CEI 183/23
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Disease Chronic; HEPATITIS C VIRUS CHRONIC INFECTION

Keywords

liver disease chronic; hcv; resveratrol; quercetin; taurine; inulin; frailty; whey protein

Outcome Measures

Primary Outcomes (3)

• Liver function measurements

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

  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.

  From enrollment to the end of treatment at 12 weeks

• Frailty

  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 Outcomes (2)

• Pro-inflammatory cytokines

  From enrollment to the end of treatment at 12 weeks

• Antioxidant activity

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Suplement

EXPERIMENTAL

powdered supplement containing resveratrol, quercetin, taurine, insulin, and whey protein.

Dietary Supplement: resveratrol, quercetin, taurine, whey protein, and inulin

Whey protein

ACTIVE COMPARATOR

Whey protein

Dietary Supplement: whey protein

Interventions

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

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

Suplement

whey protein DIETARY_SUPPLEMENT

powdered supplement containing whey protein

Whey protein

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: collaborator
• University of Guadalajara: lead
• Hospital Civil de Guadalajara: collaborator

Study Sites (2)

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

RECRUITING

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

RECRUITING

Related Publications (10)

• Li N, Cui C, Xu J, Mi M, Wang J, Qin Y. Quercetin intervention reduced hepatic fat deposition in patients with nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled crossover clinical trial. Am J Clin Nutr. 2024 Sep;120(3):507-517. doi: 10.1016/j.ajcnut.2024.07.013. Epub 2024 Jul 19.

  PMID: 39032786 RESULT

• Lu NT, Crespi CM, Liu NM, Vu JQ, Ahmadieh Y, Wu S, Lin S, McClune A, Durazo F, Saab S, Han S, Neiman DC, Beaven S, French SW. A Phase I Dose Escalation Study Demonstrates Quercetin Safety and Explores Potential for Bioflavonoid Antivirals in Patients with Chronic Hepatitis C. Phytother Res. 2016 Jan;30(1):160-8. doi: 10.1002/ptr.5518. Epub 2015 Dec 1.

  PMID: 26621580 RESULT

• Vidot H, Cvejic E, Carey S, Strasser SI, McCaughan GW, Allman-Farinelli M, Shackel NA. Randomised clinical trial: oral taurine supplementation versus placebo reduces muscle cramps in patients with chronic liver disease. Aliment Pharmacol Ther. 2018 Oct;48(7):704-712. doi: 10.1111/apt.14950. Epub 2018 Aug 23.

  PMID: 30136291 RESULT

• Schwarzer R, Kivaranovic D, Mandorfer M, Paternostro R, Wolrab D, Heinisch B, Reiberger T, Ferlitsch M, Gerner C, Trauner M, Peck-Radosavljevic M, Ferlitsch A. Randomised clinical study: the effects of oral taurine 6g/day vs placebo on portal hypertension. Aliment Pharmacol Ther. 2018 Jan;47(1):86-94. doi: 10.1111/apt.14377. Epub 2017 Nov 3.

  PMID: 29105115 RESULT

• Bomhof MR, Parnell JA, Ramay HR, Crotty P, Rioux KP, Probert CS, Jayakumar S, Raman M, Reimer RA. Histological improvement of non-alcoholic steatohepatitis with a prebiotic: a pilot clinical trial. Eur J Nutr. 2019 Jun;58(4):1735-1745. doi: 10.1007/s00394-018-1721-2. Epub 2018 May 19.

  PMID: 29779170 RESULT

• Elattar G, Saleh Z, El-Shebini S, Farrag A, Zoheiry M, Hassanein A, El-Ghannam M, Shendy S, El-Dabaa E, Zahran N. The use of whey protein concentrate in management of chronic hepatitis C virus - a pilot study. Arch Med Sci. 2010 Oct;6(5):748-55. doi: 10.5114/aoms.2010.17091. Epub 2010 Oct 26.

  PMID: 22419935 RESULT

• Chitapanarux T, Tienboon P, Pojchamarnwiputh S, Leelarungrayub D. Open-labeled pilot study of cysteine-rich whey protein isolate supplementation for nonalcoholic steatohepatitis patients. J Gastroenterol Hepatol. 2009 Jun;24(6):1045-50. doi: 10.1111/j.1440-1746.2009.05865.x.

  PMID: 19638084 RESULT

• Chen S, Zhao X, Ran L, Wan J, Wang X, Qin Y, Shu F, Gao Y, Yuan L, Zhang Q, Mi M. Resveratrol improves insulin resistance, glucose and lipid metabolism in patients with non-alcoholic fatty liver disease: a randomized controlled trial. Dig Liver Dis. 2015 Mar;47(3):226-32. doi: 10.1016/j.dld.2014.11.015. Epub 2014 Dec 16.

  PMID: 25577300 RESULT

• Pennisi M, Bertino G, Gagliano C, Malaguarnera M, Bella R, Borzi AM, Madeddu R, Drago F, Malaguarnera G. Resveratrol in Hepatitis C Patients Treated with Pegylated-Interferon-alpha-2b and Ribavirin Reduces Sleep Disturbance. Nutrients. 2017 Aug 18;9(8):897. doi: 10.3390/nu9080897.

  PMID: 28820468 RESULT

• Faghihzadeh F, Adibi P, Rafiei R, Hekmatdoost A. Resveratrol supplementation improves inflammatory biomarkers in patients with nonalcoholic fatty liver disease. Nutr Res. 2014 Oct;34(10):837-43. doi: 10.1016/j.nutres.2014.09.005. Epub 2014 Sep 23.

  PMID: 25311610 RESULT

MeSH Terms

Conditions

Hepatitis C; Frailty

Interventions

Resveratrol; Quercetin; Taurine; Whey Proteins; Inulin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Central Study Contacts

Juan Roberto Rodriguez-Echevarria, PhD

CONTACT

+52 33 18 23 13 10; roberto.rodriguez@academico.udg.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Financial Institution is also blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: October 11, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

ME (2)