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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01408966
Enrollment
22
Registered
2011-08-03
Start date
2008-08-31
Completion date
2009-06-30
Last updated
2011-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Portal Hypertension

Keywords

Dark chocolate, Catechins, Intrahepatic endothelial dysfunction, Cirrhosis, Portal Hypertension

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.

Interventions

DIETARY_SUPPLEMENTDarkChocolate

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.

DIETARY_SUPPLEMENTWhiteChocolate

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

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Consorcio Centro de Investigación Biomédica en Red (CIBER)
CollaboratorOTHER_GOV
Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Postprandial change in HVPG (% change and absolute change in mmHg)30 minutes

Secondary

MeasureTime frame
Post-prandial change in portal vein blood flow by US-Doppler30 minutes
Post-prandial change in nitric oxide metabolites30 minutes
Post-prandial changes in catechin and epicatechin30 minutes
Post-prandial changes in mean arterial pressure30 minutes

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026