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).
| Registry | NCT07487623, acronym RESQUETI |
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| Status | Recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: triple, supportive care |
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| Enrollment | 26 (Estimated) |
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| Sponsor | University of Guadalajara (Other); collaborators: Hospital Civil de Guadalajara, Centro Universitario de Ciencias de la Salud, Mexico |
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| Conditions | Liver Disease Chronic, HEPATITIS C VIRUS CHRONIC INFECTION |
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| Interventions | resveratrol, quercetin, taurine, whey protein, and inulin, whey protein (Dietary supplement) |
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| Dates | start 2025-10-11, primary completion 2026-03-31 (estimated), completion 2026-05-15 (estimated), first posted 2026-03-23, last updated 2026-03-23 |
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| Locations | 2 sites in Mexico |
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Related Papers Related Patents Related Grants Related Experts
All trials for Liver Disease Chronic All trials for HEPATITIS C VIRUS CHRONIC INFECTION All trials of resveratrol, quercetin, taurine, whey protein, and inulin All trials of whey protein
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Suplement | Experimental | Dietary Supplement: resveratrol, quercetin, taurine, whey protein, and inulin | powdered supplement containing resveratrol, quercetin, taurine, insulin, and whey protein. |
| Whey protein | Active comparator | Dietary Supplement: whey protein | Whey protein |
- 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
+Outcome measures
Primary outcomes
- 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 outcomes
- 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)
+Eligibility
Sex: All, ages: 18 Years to 69 Years
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.
+Locations (2)
| Facility | City | Country | Status |
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| Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara, Jalisco | Mexico | Recruiting |
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara, Jalisco | Mexico | Recruiting |
+Publications
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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