CirrhosisPhase 2NCT01408966
Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
A Phase 2 study testing DarkChocolate and WhiteChocolate in people with Cirrhosis and Portal Hypertension, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Portal Hypertension
- What is being tested?
- DarkChocolate and WhiteChocolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- portal vein thrombosis
- cardiac or respiratory failure
- previous surgical or transjugular intrahepatic portosystemic shunt
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.
Barcelona, 08036
About this study
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
Read the 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.
- Conditions
- Cirrhosis, Portal Hypertension
- Being tested
- DarkChocolate, WhiteChocolate
- Keywords
- Dark chocolate, Catechins, Intrahepatic endothelial dysfunction, Cirrhosis, Portal Hypertension
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarkChocolateDietary supplement
Also called Lindt Excellence 85% Cocoa, Lindt & Sprüngli España
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.
WhiteChocolateDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| DarkChocolate | Experimental | 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 Receives: Dietary Supplement: DarkChocolate |
| White chocolate supplementation | Placebo comparator | 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. Receives: Dietary Supplement: WhiteChocolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial change in HVPG (% change and absolute change in mmHg)
Measured: 30 minutes
Secondary outcomes (4)
Post-prandial change in portal vein blood flow by US-Doppler
Measured: 30 minutes
Post-prandial change in nitric oxide metabolites
Measured: 30 minutes
Post-prandial changes in catechin and epicatechin
Measured: 30 minutes
Post-prandial changes in mean arterial pressure
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startAug 2008
- Primary completionOct 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Consorcio Centro de Investigación Biomédica en Red (CIBER)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408966
- Sponsor's protocol ID
- DarkChocolateinHTP2008
- Status last verified
- Aug 2011
- First submitted
- 2 Aug 2011
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22811444
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis
- ClinicalTrials.gov ID
- NCT01408966
- Acronym / sponsor ID
- DarkChocolateinHTP2008
- Conditions
- Cirrhosis, Portal Hypertension
- Keywords
- Dark chocolate, Catechins, Intrahepatic endothelial dysfunction, Cirrhosis, Portal Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Study start
- Aug 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DarkChocolate | Experimental | Dietary Supplement: DarkChocolate11 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 |
| White chocolate supplementation | Placebo comparator | Dietary Supplement: WhiteChocolate11 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarkChocolateAlso: Lindt Excellence 85% Cocoa, Lindt & Sprüngli EspañaDark 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 supplement | DarkChocolate |
| WhiteChocolateWhite 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 | Dietary supplement | White chocolate supplementation |
Primary outcome
Postprandial change in HVPG (% change and absolute change in mmHg)
Time frame: 30 minutes
4 secondary outcomes
Post-prandial change in portal vein blood flow by US-Doppler
Time frame: 30 minutes
Post-prandial change in nitric oxide metabolites
Time frame: 30 minutes
Post-prandial changes in catechin and epicatechin
Time frame: 30 minutes
Post-prandial changes in mean arterial pressure
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2011.
- Derived from this study: PubMed 22811444De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DarkChocolate and WhiteChocolate in people with Cirrhosis and Portal Hypertension, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial change in HVPG (% change and absolute change in mmHg) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01408966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2011.