Effects of Chocolate in Patients With Chronic Heart Failure

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00538941
First received: October 1, 2007
Last updated: October 27, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Heart Failure
Dietary Supplement: Nestlé Noir intense 40 grx2
Dietary Supplement: Nestlé Placebo Chocolate 40 grx2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Swiss Dark Chocolate on Endothelial and Baroreceptor Function and Markers of Inflammation in Patients With Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • endothelial function [ Time Frame: acute (2 hours), chronic (2 and 4 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: November 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538941

Locations
Switzerland
Cardiovascular Center, Cardiology, University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Georg Noll, MD Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. med. Roberto Corti, University of Zurich
ClinicalTrials.gov Identifier: NCT00538941     History of Changes
Other Study ID Numbers: EK1124_Chocolate_CHF
Study First Received: October 1, 2007
Last Updated: October 27, 2009
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University of Zurich:
chocolate,
heart failure,
endothelial function,
platelet adhesion,
oxidative stress,
baroreceptor function,

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014