Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
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|ClinicalTrials.gov Identifier: NCT01408966|
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : August 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cirrhosis Portal Hypertension||Dietary Supplement: DarkChocolate Dietary Supplement: WhiteChocolate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||June 2009|
11 patients were randomized to receiving dark chocolate 0.55 g/kg of body weight (Lindt Excellence 85% Cocoa, Lindt & Sprüngli España) together with the test meal
Dietary Supplement: DarkChocolate
Dark 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.
Other Name: Lindt Excellence 85% Cocoa, Lindt & Sprüngli España
Placebo Comparator: White chocolate supplementation
11 patients received 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.
Dietary Supplement: WhiteChocolate
White 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
- Postprandial change in HVPG (% change and absolute change in mmHg) [ Time Frame: 30 minutes ]
- Post-prandial change in portal vein blood flow by US-Doppler [ Time Frame: 30 minutes ]
- Post-prandial change in nitric oxide metabolites [ Time Frame: 30 minutes ]
- Post-prandial changes in catechin and epicatechin [ Time Frame: 30 minutes ]
- Post-prandial changes in mean arterial pressure [ Time Frame: 30 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408966
|Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.|
|Barcelona, Spain, 08036|