Coffee Effect in HCV-related Hepatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fabio Farinati, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier:
NCT01572103
First received: April 2, 2012
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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: 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 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of coffee exposure on changes in apoptosis [ Time Frame: Time 0, 4 weeks and 8 weeks (exposure and abstinence, respectively) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: April 2, 2012
Last Updated: April 4, 2012
Health Authority: Italy: Ethic Committee Azienda Ospedaliera di Padova

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014