Effects of Chocolate in Patients With Chronic Heart Failure
This study has been completed.
Sponsor:
University of Zurich
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00538941
First received: October 1, 2007
Last updated: October 27, 2009
Last verified: October 2009
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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:
- 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
Contacts and Locations
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 May 23, 2013