Evaluation of the Hepatoprotective Effects of a Nutritional Supplement in Patients With Liver Disease Secondary to Chronic Hepatitis C Virus Infection (RESQUETI Study).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: resveratrol, quercetin, taurine, whey protein, and inulin, whey protein.
- Who it may be relevant to
- Registry conditions: Liver Disease Chronic, HEPATITIS C VIRUS CHRONIC INFECTION. Basic parameters: 18 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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).
Overview
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.
Interventions
- Dietary supplement resveratrol, quercetin, taurine, whey protein, and inulin
powdered supplement containing resveratrol, quercetin, taurine, whey protein, and inulin - Dietary supplement whey protein
powdered supplement containing whey protein
Primary outcome measures
- Liver function measurements [Time frame: 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]
- 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).]
Secondary outcome measures (2)
- Pro-inflammatory cytokines [Time frame: From enrollment to the end of treatment at 12 weeks]
- Antioxidant activity [Time frame: From enrollment to the end of treatment at 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Mexico · 2 centers
- Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara
- Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07487623 · CEI 183/23