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

Официальное название

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).

Обзор

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.

Вмешательства

• Пищевая добавка resveratrol, quercetin, taurine, whey protein, and inulin
  powdered supplement containing resveratrol, quercetin, taurine, whey protein, and inulin
• Пищевая добавка whey protein
  powdered supplement containing whey protein

Первичные конечные точки

• Liver function measurements [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Quality of life (CLDQ) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Frailty [Срок оценки: 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).]

Вторичные конечные точки (2)

• Pro-inflammatory cytokines [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Antioxidant activity [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

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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Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Мексика · 2 центра

• Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara
• Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara

Публикации

• 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

Идентификаторы

NCT: NCT07487623 · CEI 183/23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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