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

Phase 2

Completed

• Conditions: Cirrhosis; Portal Hypertension
• Interventions: Dietary Supplement: DarkChocolate; Dietary Supplement: WhiteChocolate

• Registration Number: NCT01408966
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-10
• Study Completion: 2009-06
• Status Verified: 2011-08
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-02
• Last Update Submitted: 2011-08-02
• Study First Posted: 2011-08-03
• Last Update Posted: 2011-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DarkChocolate	DarkChocolate	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
White chocolate supplementation	WhiteChocolate	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.

Primary Outcome Measures

Name	Time	Method
Postprandial change in HVPG (% change and absolute change in mmHg)	30 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.; 🇪🇸 Barcelona, Spain