NCT01408966

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
Last Updated

August 3, 2011

Status Verified

August 1, 2011

Enrollment Period

2 months

First QC Date

August 2, 2011

Last Update Submit

August 2, 2011

Conditions

CirrhosisPortal Hypertension

Keywords

Dark chocolateCatechinsIntrahepatic endothelial dysfunctionCirrhosisPortal Hypertension

Outcome Measures

Primary Outcomes (1)

  • Postprandial change in HVPG (% change and absolute change in mmHg)

    30 minutes

Secondary Outcomes (4)

  • Post-prandial change in portal vein blood flow by US-Doppler

    30 minutes

  • Post-prandial change in nitric oxide metabolites

    30 minutes

  • Post-prandial changes in catechin and epicatechin

    30 minutes

  • Post-prandial changes in mean arterial pressure

    30 minutes

Study Arms (2)

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

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.

Dietary Supplement: WhiteChocolate

Interventions

DarkChocolateDIETARY_SUPPLEMENT

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.

Also known as: Lindt Excellence 85% Cocoa, Lindt & Sprüngli España
DarkChocolate
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

White chocolate supplementation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatic Hemodynamic Laboratory. Liver Unit. Hospital Clinic.

Barcelona, 08036, Spain

Location

Related Publications (1)

  • 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.

    PMID: 22811444DERIVED

MeSH Terms

Conditions

FibrosisHypertension, Portal

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 3, 2011

Study Start

August 1, 2008

Primary Completion

October 1, 2008

Study Completion

June 1, 2009

Last Updated

August 3, 2011

Record last verified: 2011-08

Locations

ES(1)