Coffee Consumption and Oxidative DNA Damage, Apoptosis and Collagen Synthesis in HCV-related Liver Disease: a Prospective Randomized Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Variations in DNA oxidative damage levels following coffee exposure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •ongoing interferon treatment
- •history of relevant cardiomyopathy
结局指标
主要结局
Variations in DNA oxidative damage levels following coffee exposure
时间窗: Time0, 4 weeks and 8 weeks (exposure and abstinence, respectively)
次要结局
- 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))
研究者
Fabio Farinati
Associate Professor of Gastroenterology, Padua University
Azienda Ospedaliera di Padova