Effects of Chocolate in Patients With Chronic Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Dietary Supplement: Nestlé Noir intense 40 grx2; Dietary Supplement: Nestlé Placebo Chocolate 40 grx2

• Registration Number: NCT00538941
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2007-10-01
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-03
• Status Verified: 2009-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2009-10-27
• Last Update Posted: 2009-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Nestlé Noir intense 40 grx2	daily intake of 40gr chocolate (Nestlé Noir intense) in the morning and 40gr chocolate in the evening.
2	Nestlé Placebo Chocolate 40 grx2	Nestlé Placebo Chocolate 40gr in the morning and 40gr chocolate in the evening.

Primary Outcome Measures

Name	Time	Method
endothelial function	acute (2 hours), chronic (2 and 4 weeks)

Secondary Outcome Measures

Name	Time	Method
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.	acute (2 hours), chronic (2 and 4 weeks)

Trial Locations

Locations (1)

Cardiovascular Center, Cardiology, University Hospital of Zurich; 🇨🇭 Zurich, Switzerland