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Coffee Effect in HCV-related Hepatitis

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 6, 2012
Last Update Posted: April 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fabio Farinati, Azienda Ospedaliera di Padova
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.

Condition Intervention Phase
Chronic HCV-related Hepatitis Dietary Supplement: Coffee Dietary Supplement: coffee abstinence Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Coffee Consumption and Oxidative DNA Damage, Apoptosis and Collagen Synthesis in HCV-related Liver Disease: a Prospective Randomized Trial.

Resource links provided by NLM:

Further study details as provided by Fabio Farinati, Azienda Ospedaliera di Padova:

Primary Outcome Measures:
  • Variations in DNA oxidative damage levels following coffee exposure [ Time Frame: Time0, 4 weeks and 8 weeks (exposure and abstinence, respectively) ]

Secondary Outcome Measures:
  • Effect of coffee exposure on changes in apoptosis [ Time Frame: Time 0, 4 weeks and 8 weeks (exposure and abstinence, respectively) ]
  • Changes in collagen synthesis following coffee exposure in HCV-related hepatitis patients [ Time Frame: Time 0, 4 weeks and 8 weeks (exposure and abstinence, respectively) ]

Enrollment: 40
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Administration of coffee
Administration of 4 cups of coffee/day for 1 month
Dietary Supplement: Coffee
Administration of 4 cups of coffee per day for 1 month
No Intervention: Coffee abstinence
Total coffee and caffeine containing beverages abstinence
Dietary Supplement: coffee abstinence
total abstinence for both coffee and caffeine containing beverages

  Show Detailed Description


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Fabio Farinati, Associate Professor of Gastroenterology, Padua University, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT01572103     History of Changes
Other Study ID Numbers: ISIC
First Submitted: April 2, 2012
First Posted: April 6, 2012
Last Update Posted: April 6, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases