Clinical trial NCT01408966: Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
Official title: Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cirrhosis
Portal Hypertension
Keywords: Dark chocolate
Catechins
Intrahepatic endothelial dysfunction
Cirrhosis
Portal Hypertension
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
First posted: 2011-08-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 pressure gradient (HVPG, clinical equivalent of portal pressure) in patients with cirrhosis

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 leads to a brisk increase in portal pressure (estimated by the HVPG). This method is therefore useful to assess the efficacy of compounds potentially ameliorating intrahepatic endothelial dysfunction. Dark chocolate, which contains a high proportion of cocoa flavonoids such as cathechin and epicatechin- powerful antioxidants, increases NO availability in the systemic circulation and improves systemic endothelial function. We hypothesised that the antioxidant properties of dark chocolate could be beneficial in patients with cirrhosis, since they might improve intrahepatic endothelial dysfunction. Consequently, the aim of this study was to evaluate whether a dark chocolate-containing test meal may attenuate the post-prandial increase in HVPG in patients with cirrhosis and portal hypertension.

HVPG was measured at baseline and 30 minutes after the administration of a test meal supplemented by either dark or white chocolate. Portal vein blood flow and hepatic artery blood flow were measured by Doppler ultrasound. Catechins and NOx were determined for both timepoints.

Eligibility criteria: Inclusion Criteria:

1. age over 18 years
2. diagnosis of cirrhosis (proven by biopsy or clinical, laboratory and imaging procedures)
3. presence of esophageal varices of any grade
4. HVPG ≥ 10 mmHg during the hemodynamic study

Exclusion Criteria:

1. food allergy to chocolate
2. ongoing treatment with ascorbic acid and/or other antioxidants
3. diffuse or multinodular hepatocellular carcinoma
4. pregnancy
5. advanced hepatic failure (defined as prothrombin ratio \< 40% and bilirubin \> 5 mg/dL)
6. renal failure (defined by a serum creatinine level \> 1.5 mg/dL)
7. portal vein thrombosis
8. cardiac or respiratory failure
9. previous surgical or transjugular intrahepatic portosystemic shunt

Primary outcomes:
measure: Postprandial change in HVPG (% change and absolute change in mmHg)
timeFrame: 30 minutes
Secondary outcomes:
measure: Post-prandial change in portal vein blood flow by US-Doppler
timeFrame: 30 minutes
measure: Post-prandial change in nitric oxide metabolites
timeFrame: 30 minutes
measure: Post-prandial changes in catechin and epicatechin
timeFrame: 30 minutes
measure: Post-prandial changes in mean arterial pressure
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
Study officials:
References:
citation: De Gottardi A, Berzigotti A, Seijo S, D'Amico M, Thormann W, Abraldes JG, Garcia-Pagan JC, Bosch J. Postprandial effects of dark chocolate on portal hypertension in patients with cirrhosis: results of a phase 2, double-blind, randomized controlled trial. Am J Clin Nutr. 2012 Sep;96(3):584-90. doi: 10.3945/ajcn.112.040469. Epub 2012 Jul 18.