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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408966
• Other study ID #: DarkChocolateinHTP2008
• Status: Completed
• Phase: Phase 2
• First received: August 2, 2011
• Last updated: August 2, 2011
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: August 2011
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

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.
• 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

Locations

Country	Name	City	State
Spain	Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Centro de Investigación Biomédica en Red, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial change in HVPG (% change and absolute change in mmHg)		30 minutes	No
Secondary	Post-prandial change in portal vein blood flow by US-Doppler		30 minutes	No
Secondary	Post-prandial change in nitric oxide metabolites		30 minutes	No
Secondary	Post-prandial changes in catechin and epicatechin		30 minutes	No
Secondary	Post-prandial changes in mean arterial pressure		30 minutes	No