Heart FailureNCT00538941
Effects of Chocolate in Patients With Chronic Heart Failure
A study testing Nestlé Noir intense 40 grx2 in people with Heart Failure, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Nestlé Noir intense 40 grx2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2005to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure ( NYHA ≥II, LVEF<50%, independent of aetiology)
- Nonsmokers
- Age: 30-80
- Written obtained informed consent
Who cannot join
- Decompensated Heart failure
- Instable Angina pectoris
- Smokers
- Ventricular tachyarrhythmias or AV-Block >I°
- Renal failure (>200 umol)
- Liver disease (ALT or AST >150 IU)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cardiovascular Center, Cardiology, University Hospital of Zurich
Zurich, 8091
About this study
Official title: Effects of Swiss Dark Chocolate on Endothelial and Baroreceptor Function and Markers of Inflammation in Patients With Chronic Heart Failure
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.
- Conditions
- Heart Failure
- Being tested
- Nestlé Noir intense 40 grx2, Nestlé Placebo Chocolate 40 grx2
- Keywords
- chocolate,, heart failure,, endothelial function,, platelet adhesion,, oxidative stress,, baroreceptor function,
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nestlé Noir intense 40 grx2Dietary supplement
daily intake of 40gr chocolate (Nestlé Noir intense or Nestlé Placebo Chocolate) in the morning and 40gr chocolate in the evening.
Nestlé Placebo Chocolate 40 grx2Dietary supplement
Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | daily intake of 40gr chocolate (Nestlé Noir intense) in the morning and 40gr chocolate in the evening. Receives: Dietary Supplement: Nestlé Noir intense 40 grx2 |
| 2 | Placebo comparator | Nestlé Placebo Chocolate 40gr in the morning and 40gr chocolate in the evening. Receives: Dietary Supplement: Nestlé Placebo Chocolate 40 grx2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial function
Measured: acute (2 hours), chronic (2 and 4 weeks)
Secondary outcomes (1)
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.
Measured: acute (2 hours), chronic (2 and 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startNov 2005
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Georg Noll, MD, Principal investigator, Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538941
- Sponsor's protocol ID
- EK1124_Chocolate_CHF
- Status last verified
- Oct 2009
- First submitted
- 1 Oct 2007
- Last updated
- 28 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22173910
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Swiss Dark Chocolate on Endothelial and Baroreceptor Function and Markers of Inflammation in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00538941
- Acronym / sponsor ID
- EK1124_Chocolate_CHF
- Conditions
- Heart Failure
- Keywords
- chocolate,, heart failure,, endothelial function,, platelet adhesion,, oxidative stress,, baroreceptor function,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Nestlé Noir intense 40 grx2daily intake of 40gr chocolate (Nestlé Noir intense) in the morning and 40gr chocolate in the evening. |
| 2 | Placebo comparator | Dietary Supplement: Nestlé Placebo Chocolate 40 grx2Nestlé Placebo Chocolate 40gr in the morning and 40gr chocolate in the evening. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Heart failure ( NYHA ≥II, LVEF<50%, independent of aetiology)
- Nonsmokers
- Age: 30-80
- Written obtained informed consent
Key exclusion criteria (16 listed)
- Decompensated Heart failure
- Instable Angina pectoris
- Smokers
- Ventricular tachyarrhythmias or AV-Block >I°
- Renal failure (>200 umol)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nestlé Noir intense 40 grx2daily intake of 40gr chocolate (Nestlé Noir intense or Nestlé Placebo Chocolate) in the morning and 40gr chocolate in the evening. | Dietary supplement | 1 |
| Nestlé Placebo Chocolate 40 grx2Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening. | Dietary supplement | 2 |
Primary outcome
endothelial function
Time frame: acute (2 hours), chronic (2 and 4 weeks)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2009.
- Derived from this study: PubMed 22173910Flammer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg Noll, MD principal investigator
Cardiovascular Center, University Hospital Zurich, Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nestlé Noir intense 40 grx2 in people with Heart Failure, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial function (time frame: acute (2 hours), chronic (2 and 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00538941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2009.