Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
| Tracking Information | |
|---|---|
| First Received Date ICMJE | August 2, 2011 |
| Last Updated Date | August 2, 2011 |
| Start Date ICMJE | August 2008 |
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Postprandial change in HVPG (% change and absolute change in mmHg) [ Time Frame: 30 minutes ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis |
| Official Title ICMJE | Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis |
| 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. |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 2 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | De Gottardi A, Berzigotti A, Seijo S, D'Amico M, Thormann W, Abraldes JG, García-Pagán 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. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 22 |
| Completion Date | June 2009 |
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years to 80 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Spain |
| Administrative Information | |
| NCT Number ICMJE | NCT01408966 |
| Other Study ID Numbers ICMJE | DarkChocolateinHTP2008 |
| Has Data Monitoring Committee | No |
| Responsible Party | Jaime Bosch /Professor of Medicine, University of Barcelona |
| Study Sponsor ICMJE | Hospital Clinic of Barcelona |
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided |
| Information Provided By | Hospital Clinic of Barcelona |
| Verification Date | August 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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