Effects of Chocolate in Patients With Chronic Heart Failure

October 27, 2009 updated by: University of Zurich

Effects of Swiss Dark Chocolate on Endothelial and Baroreceptor Function and Markers of Inflammation in Patients With Chronic Heart Failure

The aim of the present study is to investigate whether in patients with chronic heart failure endothelial dysfunction and baroreceptor function is altered by ingestion of a flavonoid-rich dark chocolate in comparison to placebo chocolate (Nestlé Placebo Chocolate) on top of standard medication.

Moreover, we will evaluate the effect of chocolate on oxidative stress, platelet adhesion as well as systemic inflammatory response such as C-reactive protein and pro-inflammatory cytokines in patients with chronic heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Cardiovascular Center, Cardiology, University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Heart failure ( NYHA ≥II, LVEF<50%, independent of aetiology)
  2. Nonsmokers
  3. Age: 30-80
  4. Written obtained informed consent

Exclusion Criteria:

  1. Decompensated Heart failure
  2. Instable Angina pectoris
  3. Smokers
  4. Ventricular tachyarrhythmias or AV-Block >I°
  5. Renal failure (>200 umol)
  6. Liver disease (ALT or AST >150 IU)
  7. Diabetes mellitus
  8. Obesity (BMI >30 kg/m2)
  9. Symptomatic hypotension, hypertension >160/100mmHg
  10. Known allergy to compounds of Nestlé noir intense
  11. History of gastric ulcer or bleeding, current diarrhea
  12. Venous thrombosis or pulmonary embolism, at present or recurrent history of Infectious disease, acutely or chronic
  13. Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
  14. Neoplasia (unless healed or remission >5 years)
  15. Participation in another study within the last month
  16. Concomitant vitamin supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
daily intake of 40gr chocolate (Nestlé Noir intense) in the morning and 40gr chocolate in the evening.
Dietary supplement: Nestlé Noir intense 40 grx2
daily intake of 40gr chocolate (Nestlé Noir intense or Nestlé Placebo Chocolate) in the morning and 40gr chocolate in the evening.
Placebo Comparator: 2
Nestlé Placebo Chocolate 40gr in the morning and 40gr chocolate in the evening.
Dietary supplement: Nestlé Placebo Chocolate 40 grx2
Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endothelial function
Time Frame: acute (2 hours), chronic (2 and 4 weeks)
acute (2 hours), chronic (2 and 4 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
shear-stress dependent platelet function; Oxidative stress; baroreceptor function Systemic inflammatory response (assessed as change in high sensitivity CRP, 8-Isoprostanes, CD-40 ligand); Plasma epicatechins.
Time Frame: acute (2 hours), chronic (2 and 4 weeks)
acute (2 hours), chronic (2 and 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Georg Noll, MD, Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 1, 2007

First Submitted That Met QC Criteria

October 2, 2007

First Posted (Estimate)

October 3, 2007

Study Record Updates

Last Update Posted (Estimate)

October 28, 2009

Last Update Submitted That Met QC Criteria

October 27, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK1124_Chocolate_CHF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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