Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Civil de Guadalajara | OTHER |
| Centro Universitario de Ciencias de la Salud, Mexico | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suplement | Experimental | powdered supplement containing resveratrol, quercetin, taurine, insulin, and whey protein. |
|
| Whey protein | Active Comparator | Whey protein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| resveratrol, quercetin, taurine, whey protein, and inulin | Dietary Supplement | powdered supplement containing resveratrol, quercetin, taurine, whey protein, and inulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Pro-inflammatory cytokines | Serum concentrations of pro-inflammatory cytokines (IL-1β, TNF-α, TGF-β) | From enrollment to the end of treatment at 12 weeks |
| Antioxidant activity | Serum concentrations of antioxidant enzymes superoxide dismutase (SOD) and catalase (CAT) |
Not provided
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.
-
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Roberto Rodriguez-Echevarria, PhD | Contact | +52 33 18 23 13 10 | roberto.rodriguez@academico.udg.mx |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Recruiting | Guadalajara | Jalisco | 44280 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39032786 | Result | 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. | |
| 26621580 | Result |
Not provided
Not provided
It might be considered.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The Financial Institution is also blinded.
| whey protein | Dietary Supplement | powdered supplement containing whey protein |
|
| From enrollment to the end of treatment at 12 weeks |
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Recruiting | Guadalajara | Jalisco | Mexico |
|
| 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. |
| 30136291 | 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. |
| 29105115 | 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. |
| 29779170 | 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. |
| 22419935 | 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. |
| 19638084 | 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. |
| 25577300 | 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. |
| 28820468 | 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. |
| 25311610 | 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. |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D011794 | Quercetin |
| D013654 | Taurine |
| D000067816 | Whey Proteins |
| D007444 | Inulin |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |
Not provided
Not provided