Effects of Chocolate in Patients With Chronic Heart Failure - Full Text View

Sponsored by:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00538941

Purpose

The aim of the present study is to investigate whether in patients with chronic heart failure endothelial dysfunction, intima-media-thickness 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

MedlinePlus related topics: Adhesions Dietary Supplements Heart Failure

U.S. FDA Resources

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

Further study details as provided by University of Zurich:

Primary Outcome Measures:

endothelial function; shear-stress dependent platelet function; intima-media-thickness; baroreflex function. [ Time Frame: acute (2 hours), chronic (2 and 4 weeks) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Oxidative stress; 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 ]

Estimated Enrollment:	16
Study Start Date:	November 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Placebo Comparator 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:

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 tachyarrythmias 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

Contacts and Locations

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

Contacts

Contact: Georg Noll, MD

0041 44 255 11 11

georg.noll@usz.ch

Locations

Switzerland
Cardiovascular Center, Cardiology, University Hospital of Zurich	Recruiting
Zurich, Switzerland, 8091
Contact: Georg Noll, MD 0041 44 255 11 11 georg.noll@usz.ch
Principal Investigator: Georg Noll, MD

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator:

Georg Noll, MD

Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland

More Information

Responsible Party:	University of Zurich ( PD Dr. med. Roberto Corti )
Study ID Numbers:	EK1124_Chocolate_CHF
Study First Received:	October 1, 2007
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00538941
Health Authority:	Switzerland: Ethikkommission; Switzerland: Swissmedic

Keywords provided by University of Zurich:

chocolate,
heart failure,
endothelial function,

platelet adhesion,
oxidative stress,
baroreceptor function,

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Stress
Adhesions
Inflammation

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009