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Coffee Effect in HCV-related Hepatitis

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. Identifier: NCT01572103
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : April 6, 2012
Information provided by (Responsible Party):
Fabio Farinati, Azienda Ospedaliera di Padova

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.

Condition or disease Intervention/treatment Phase
Chronic HCV-related Hepatitis Dietary Supplement: Coffee Dietary Supplement: coffee abstinence Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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.
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. Effect of coffee exposure on changes in apoptosis [ Time Frame: Time 0, 4 weeks and 8 weeks (exposure and abstinence, respectively) ]
  2. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases