Coffee Consumption and Oxidative DNA Damage, Apoptosis and Collagen Synthesis in HCV-related Liver Disease: a Prospective Randomized Trial.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- Variations in DNA oxidative damage levels following coffee exposure
Study Overview
Brief Summary
Background: In patients with chronic HCV-related liver damage, coffee is associated with a reduced risk of progression and of hepatocellular carcinoma (HCC) development. Aim: This prospective trial is aimed at assessing the mechanisms underlying the protective effect of coffee on evolution in cirrhosis and HCC. Trial design/methods: Forty patients with HCV-related hepatitis will be recruited and randomized into two groups: the first will consume 4 coffee cups/day/1 month, while the second will remain coffee "abstinent". At day 30, the two groups will be switched over and exposed to coffee or not for a second month. Before entering the study (time 0), during coffee exposure and during abstinence we will evaluate the following parameters: liver function tests, viral load, 8-hydroxydeoxyguanosine (a marker of oxidative DNA damage), telomere length, apoptosis and collagen deposition.
Detailed Description
Patients Forty patients with HCV-related chronic liver disease referring to the Gastroenterology Unit of Padua out-patient clinic will be prospectively recruited and will enter the study.
In all patients the presence of anti-HCV antibodies will be assayed by a third-generation immunoenzymatic test (Ortho Diagnostic Systems, Raritan, NJ) and by confirmatory test (recombinant immunoblotting assay, Chiron Corp., Emeryville, CA). A standardized genotyping assay (Inno-Lipa HCV III, Innogenetics, Gent, Belgium) will be used.
Only patients who fulfill the following inclusion criteria will be recruited:
- HCV-related chronic hepatitis or cirrhosis, with bioptic (within the previous 24 months) confirmation or a clinical diagnosis in case of cirrhosis; (Prothrombin Time - PT, White Blood Cells - WBC and platelets - PLT, Ultra Sound - US examination);
- anti-HCV and HCV-RNA positivity with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) at least 1.5x;
- age range 30-80 years;
- no ongoing interferon treatment, previous treatment with no response or relapse was accepted.
The study is approved by the Hospital Ethical Committee (Prot. 1755 P, Azienda Ospedaliera di Padova), the patients' participation is voluntary and each patient signs an informed consent to participation, an information note being delivered to each patient's attending general practitioner.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HCV-related chronic hepatitis or cirrhosis, with bioptic (within the previous 24 months) confirmation or a clinical diagnosis in case of cirrhosis (Prothrombin Time - PT, White Blood Cells - WBC and platelets - PLT, Ultra Sound - US examination suggestive for cirrhosis);
- •anti-HCV and HCV-RNA positivity with AST/ALT at least 1.5x;
- •age range 30-80 years;
- •no ongoing interferon treatment, previous treatment with no response or relapse was accepted.
Exclusion Criteria
- •ongoing interferon treatment
- •history of relevant cardiomyopathy
Outcomes
Primary Outcomes
Variations in DNA oxidative damage levels following coffee exposure
Time Frame: Time0, 4 weeks and 8 weeks (exposure and abstinence, respectively)
Secondary Outcomes
- Effect of coffee exposure on changes in apoptosis(Time 0, 4 weeks and 8 weeks (exposure and abstinence, respectively))
- Changes in collagen synthesis following coffee exposure in HCV-related hepatitis patients(Time 0, 4 weeks and 8 weeks (exposure and abstinence, respectively))
Investigators
Fabio Farinati
Associate Professor of Gastroenterology, Padua University
Azienda Ospedaliera di Padova