Effects of Chocolate in Patients With Chronic Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Nestlé Noir intense 40 grx2
Nestlé Placebo Chocolate 40 grx2
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring chocolate,, heart failure,, endothelial function,, platelet adhesion,, oxidative stress,, baroreceptor function,
Eligibility 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 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
Sites / Locations
- Cardiovascular Center, Cardiology, University Hospital of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
daily intake of 40gr chocolate (Nestlé Noir intense) in the morning and 40gr chocolate in the evening.
Nestlé Placebo Chocolate 40gr in the morning and 40gr chocolate in the evening.
Outcomes
Primary Outcome Measures
endothelial function
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00538941
Brief Title
Effects of Chocolate in Patients With Chronic Heart Failure
Official Title
Effects of Swiss Dark Chocolate on Endothelial and Baroreceptor Function and Markers of Inflammation in Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
chocolate,, heart failure,, endothelial function,, platelet adhesion,, oxidative stress,, baroreceptor function,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
daily intake of 40gr chocolate (Nestlé Noir intense) in the morning and 40gr chocolate in the evening.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Nestlé Placebo Chocolate 40gr in the morning and 40gr chocolate in the evening.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nestlé Noir intense 40 grx2
Intervention Description
daily intake of 40gr chocolate (Nestlé Noir intense or Nestlé Placebo Chocolate) in the morning and 40gr chocolate in the evening.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nestlé Placebo Chocolate 40 grx2
Intervention Description
Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening.
Primary Outcome Measure Information:
Title
endothelial function
Time Frame
acute (2 hours), chronic (2 and 4 weeks)
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Noll, MD
Organizational Affiliation
Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Center, Cardiology, University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22173910
Citation
Flammer AJ, Sudano I, Wolfrum M, Thomas R, Enseleit F, Periat D, Kaiser P, Hirt A, Hermann M, Serafini M, Leveques A, Luscher TF, Ruschitzka F, Noll G, Corti R. Cardiovascular effects of flavanol-rich chocolate in patients with heart failure. Eur Heart J. 2012 Sep;33(17):2172-80. doi: 10.1093/eurheartj/ehr448. Epub 2011 Dec 15.
Results Reference
derived
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Effects of Chocolate in Patients With Chronic Heart Failure
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