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Completed

NCT Number: NCT01408966

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

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

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Key information

Conditions

Cirrhosis Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DarkChocolate

Dietary Supplement

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 names: Lindt Excellence 85% Cocoa, Lindt & Sprüngli España

WhiteChocolate

Dietary Supplement

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

Primary outcomes

  1. Postprandial change in HVPG (% change and absolute change in mmHg)

    Time frame: 30 minutes

Secondary outcomes

  1. Post-prandial change in portal vein blood flow by US-Doppler

    Time frame: 30 minutes

  2. Post-prandial change in nitric oxide metabolites

    Time frame: 30 minutes

  3. Post-prandial changes in catechin and epicatechin

    Time frame: 30 minutes

  4. Post-prandial changes in mean arterial pressure

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)
  • Instituto de Salud Carlos III

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Aug 3, 2011
Registry last updated
Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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