Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
Primary Purpose
Cirrhosis, Portal Hypertension
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
DarkChocolate
WhiteChocolate
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis focused on measuring Dark chocolate, Catechins, Intrahepatic endothelial dysfunction, Cirrhosis, Portal Hypertension
Eligibility Criteria
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
Sites / Locations
- Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
DarkChocolate
White chocolate supplementation
Arm 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
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.
Outcomes
Primary Outcome Measures
Postprandial change in HVPG (% change and absolute change in mmHg)
Secondary Outcome Measures
Post-prandial change in portal vein blood flow by US-Doppler
Post-prandial change in nitric oxide metabolites
Post-prandial changes in catechin and epicatechin
Post-prandial changes in mean arterial pressure
Full Information
NCT ID
NCT01408966
First Posted
August 2, 2011
Last Updated
August 2, 2011
Sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III, Consorcio Centro de Investigación Biomédica en Red (CIBER)
1. Study Identification
Unique Protocol Identification Number
NCT01408966
Brief Title
Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
Official Title
Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Instituto de Salud Carlos III, Consorcio Centro de Investigación Biomédica en Red (CIBER)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Portal Hypertension
Keywords
Dark chocolate, Catechins, Intrahepatic endothelial dysfunction, Cirrhosis, Portal Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DarkChocolate
Arm Type
Experimental
Arm 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
Arm Title
White chocolate supplementation
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
DarkChocolate
Other Intervention Name(s)
Lindt Excellence 85% Cocoa, Lindt & Sprüngli España
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
WhiteChocolate
Intervention Description
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 Outcome Measure Information:
Title
Postprandial change in HVPG (% change and absolute change in mmHg)
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Post-prandial change in portal vein blood flow by US-Doppler
Time Frame
30 minutes
Title
Post-prandial change in nitric oxide metabolites
Time Frame
30 minutes
Title
Post-prandial changes in catechin and epicatechin
Time Frame
30 minutes
Title
Post-prandial changes in mean arterial pressure
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
22811444
Citation
De Gottardi A, Berzigotti A, Seijo S, D'Amico M, Thormann W, Abraldes JG, Garcia-Pagan 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.
Results Reference
derived
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Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
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