Effects of Chocolate in Patients With Chronic Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Nestlé Noir intense 40 grx2

Intervention Type DIETARY_SUPPLEMENT

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

2

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

Group Type PLACEBO_COMPARATOR

Nestlé Placebo Chocolate 40 grx2

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Nestlé Placebo Chocolate 40 grx2

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No