Status:
COMPLETED
Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Instituto de Salud Carlos III
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Conditions:
Cirrhosis
Portal Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study was aimed at testing the hypothesis that supplementing a meal with dark chocolate, which holds potent antioxidant properties, might attenuate the postprandial increase in the hepatic venous...
Detailed Description
Previous studies showed that the intrahepatic circulation in cirrhosis is not able to adapt to sudden increases in blood flow, such as that occurring after a meal, due to endothelial dysfunction. This...
Eligibility Criteria
Inclusion
- age over 18 years
- diagnosis of cirrhosis (proven by biopsy or clinical, laboratory and imaging procedures)
- presence of esophageal varices of any grade
- HVPG ≥ 10 mmHg during the hemodynamic study
Exclusion
- food allergy to chocolate
- ongoing treatment with ascorbic acid and/or other antioxidants
- diffuse or multinodular hepatocellular carcinoma
- pregnancy
- advanced hepatic failure (defined as prothrombin ratio \< 40% and bilirubin \> 5 mg/dL)
- renal failure (defined by a serum creatinine level \> 1.5 mg/dL)
- portal vein thrombosis
- cardiac or respiratory failure
- previous surgical or transjugular intrahepatic portosystemic shunt
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01408966
Start Date
August 1 2008
End Date
June 1 2009
Last Update
August 3 2011
Active Locations (1)
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1
Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
Barcelona, Spain, 08036