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

This study has been completed.
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Centro de Investigación Biomédica en Red
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01408966
First received: August 2, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

August 2, 2011
August 2, 2011
August 2008
October 2008   (final data collection date for primary outcome measure)
Postprandial change in HVPG (% change and absolute change in mmHg) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Post-prandial change in portal vein blood flow by US-Doppler [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Post-prandial change in nitric oxide metabolites [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Post-prandial changes in catechin and epicatechin [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Post-prandial changes in mean arterial pressure [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Cirrhosis
  • Portal Hypertension
  • 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
  • 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
  • Experimental: 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
    Intervention: Dietary Supplement: DarkChocolate
  • 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.
    Intervention: Dietary Supplement: WhiteChocolate
De Gottardi A, Berzigotti A, Seijo S, D'Amico M, Thormann W, Abraldes JG, García-Pagán JC, Bosch J. Postprandial effects of dark chocolate on portal hypertension in patients with cirrhosis: results of a phase 2, double-blind, randomized controlled trial. Am J Clin Nutr. 2012 Sep;96(3):584-90. doi: 10.3945/ajcn.112.040469. Epub 2012 Jul 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
June 2009
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01408966
DarkChocolateinHTP2008
No
Jaime Bosch /Professor of Medicine, University of Barcelona
Hospital Clinic of Barcelona
  • Instituto de Salud Carlos III
  • Centro de Investigación Biomédica en Red
Not Provided
Hospital Clinic of Barcelona
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP