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

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 2

Conditions: Portal Hypertension; Cirrhosis

Treatments: Dietary Supplement: WhiteChocolate; Dietary Supplement: DarkChocolate

Study type: Interventional

Funder types: Other

Identifiers

NCT01408966

DarkChocolateinHTP2008

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

DarkChocolate

Experimental group

Description:

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

Treatment:

Dietary Supplement: DarkChocolate

White chocolate supplementation

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: WhiteChocolate