Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
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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 |
- Postprandial change in HVPG (% change and absolute change in mmHg) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
- 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 |
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
Contacts and Locations| Spain | |
| Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic. | |
| Barcelona, Spain, 08036 | |
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 May 19, 2013