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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cirrhosis, Portal Hypertension

Intervention / Treatment
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* Dietary Supplement: DarkChocolate
* Dietary Supplement: WhiteChocolate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DarkChocolate<br>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<br>* 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.<br>* Other names: Lindt Excellence 85% Cocoa, Lindt & Sprüngli España;|
| Placebo Comparator: White chocolate supplementation<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial change in HVPG (% change and absolute change in mmHg) |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial change in portal vein blood flow by US-Doppler |  | 30 minutes | 
| Post-prandial change in nitric oxide metabolites |  | 30 minutes | 
| Post-prandial changes in catechin and epicatechin |  | 30 minutes | 
| Post-prandial changes in mean arterial pressure |  | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dark chocolate, Catechins, Intrahepatic endothelial dysfunction, Cirrhosis, Portal Hypertension