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Completed

NCT Number: NCT00538941

Effects of Chocolate 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Center, Cardiology, University Hospital of Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Nestlé Noir intense 40 grx2

Dietary Supplement

daily intake of 40gr chocolate (Nestlé Noir intense or Nestlé Placebo Chocolate) in the morning and 40gr chocolate in the evening.

Nestlé Placebo Chocolate 40 grx2

Dietary Supplement

Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening.

Primary outcomes

  1. endothelial function

    Time frame: acute (2 hours), chronic (2 and 4 weeks)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Oct 3, 2007
Registry last updated
Oct 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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