Clinical Trials Directory

Trials / Completed

CompletedNCT01408966

Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Hospital Clinic of Barcelona · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTDarkChocolateDark chocolatee 0.55 g/kg of body weight was given together with the test meal in sitting position after the baseline measurement of HVPG. The meal + chocolate was ingested in 8 minutes.
DIETARY_SUPPLEMENTWhiteChocolateWhite chocolate 0.63 g/kg white chocolate (Lindt Excellence Natural Vanilla, Lindt \& Sprüngli España) in an iso-caloric and iso-volumetric proportion adjusted to body weight was used as a control

Timeline

Start date
2008-08-01
Primary completion
2008-10-01
Completion
2009-06-01
First posted
2011-08-03
Last updated
2011-08-03

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT01408966. Inclusion in this directory is not an endorsement.