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
  Purpose

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


Condition Intervention Phase
Cirrhosis
Portal Hypertension
Dietary Supplement: DarkChocolate
Dietary Supplement: WhiteChocolate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Postprandial change in HVPG (% change and absolute change in mmHg) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408966

Locations
Spain
Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Instituto de Salud Carlos III
Centro de Investigación Biomédica en Red
  More Information

No publications provided by Hospital Clinic of Barcelona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaime Bosch /Professor of Medicine, University of Barcelona
ClinicalTrials.gov Identifier: NCT01408966     History of Changes
Other Study ID Numbers: DarkChocolateinHTP2008
Study First Received: August 2, 2011
Last Updated: August 2, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Clinic of Barcelona:
Dark chocolate
Catechins
Intrahepatic endothelial dysfunction
Cirrhosis
Portal Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Liver Cirrhosis
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014