Cardiovascular DiseasesNew DrinkNCT02149238
Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects
A study testing flavanol, methylxanthine and flavanol + methylxanthine in people with Cardiovascular Diseases, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- flavanol, methylxanthine and flavanol + methylxanthine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Dec 2014
- 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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects
- >18 years
Who cannot join
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
- diabetes mellitus
- CRP > 1 mg/dl
- malignant disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonology and Vascular Medicine
Düsseldorf, 40225
About this study
Official title: Acute Study to Investigate the Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects
Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure.
However, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.
- Conditions
- Cardiovascular Diseases
- Being tested
- flavanol, methylxanthine, flavanol + methylxanthine
- Keywords
- flavanols, cardiovascular effects, nutrition-nutrition interaction
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flavanolDietary supplement
methylxanthineDietary supplement
flavanol + methylxanthineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| flavanol rich drink intervention | Active comparator | flavanol rich drink Receives: Dietary Supplement: flavanol |
| methylxanthine rich drink intervention | Active comparator | methylxanthine rich drink Receives: Dietary Supplement: methylxanthine |
| flavanol + methylxanthine rich drink intervention | Active comparator | flavanol + methylxanthine rich drink Receives: Dietary Supplement: flavanol + methylxanthine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Flow mediated dilatation (FMD)
Measured: 2 hours
Plasma flavanol metabolites
Measured by HPLC
Measured: 2 hours
Secondary outcomes (3)
Pulse wave velocity
Measured by SphygmoCor
Measured: 2 hours
Ambulatory blood pressure
automatical measurements
Measured: 2 hours
Circulation angiogenetic cells
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startFeb 2011
- Primary completionDec 2014
- Study completionDec 2014
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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Christian Heiss, MD, Principal investigator, Division of Cardiology, Pulmonology and Vascular MedicineMalte Kelm, MD, Study chair, Division of Cardiology, Pulmonology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149238
- Sponsor's protocol ID
- New Drink
- Acronym
- New Drink
- Status last verified
- Dec 2014
- First submitted
- 22 May 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sansone R, Ottaviani JI, Rodriguez-Mateos A, Heinen Y, Noske D, Spencer JP, Crozier A, Merx MW, Kelm M, Schroeter H, Heiss C. Methylxanthines enhance the effects of cocoa flavanols on cardiovascular function: randomized, double-masked controlled studies. Am J Clin Nutr. 2017 Feb;105(2):352-360. doi: 10.3945/ajcn.116.140046. Epub 2016 Dec 21.
PubMed 28003203
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Study to Investigate the Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects
- ClinicalTrials.gov ID
- NCT02149238
- Acronym / sponsor ID
- New Drink / New Drink
- Conditions
- Cardiovascular Diseases
- Keywords
- flavanols, cardiovascular effects, nutrition-nutrition interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 May 2014 (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.
Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure.
However, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| flavanol rich drink intervention | Active comparator | Dietary Supplement: flavanolflavanol rich drink |
| methylxanthine rich drink intervention | Active comparator | Dietary Supplement: methylxanthinemethylxanthine rich drink |
| flavanol + methylxanthine rich drink intervention | Active comparator | Dietary Supplement: flavanol + methylxanthineflavanol + methylxanthine rich drink |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy male subjects
- >18 years
Key exclusion criteria (7 listed)
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
- diabetes mellitus
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 |
|---|---|---|
| flavanol | Dietary supplement | flavanol rich drink intervention |
| methylxanthine | Dietary supplement | methylxanthine rich drink intervention |
| flavanol + methylxanthine | Dietary supplement | flavanol + methylxanthine rich drink intervention |
Primary outcome
Endothelial function
Time frame: 2 hours
Flow mediated dilatation (FMD)
Plasma flavanol metabolites
Time frame: 2 hours
Measured by HPLC
3 secondary outcomes
Pulse wave velocity
Time frame: 2 hours
Ambulatory blood pressure
Time frame: 2 hours
Circulation angiogenetic cells
Time frame: 2 hours
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 23 Dec 2014.
- Derived from this study: PubMed 28003203Sansone R, Ottaviani JI, Rodriguez-Mateos A, Heinen Y, Noske D, Spencer JP, Crozier A, Merx MW, Kelm M, Schroeter H, Heiss C. Methylxanthines enhance the effects of cocoa flavanols on cardiovascular function: randomized, double-masked controlled studies. Am J Clin Nutr. 2017 Feb;105(2):352-360. doi: 10.3945/ajcn.116.140046. Epub 2016 Dec 21.
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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.
Christian Heiss, MD principal investigator
Division of Cardiology, Pulmonology and Vascular Medicine
Malte Kelm, MD study chair
Division of Cardiology, Pulmonology and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flavanol, methylxanthine and flavanol + methylxanthine in people with Cardiovascular Diseases, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 2 inclusion and 7 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 23 Dec 2014. 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 Germany. 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. 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: 2 hours). The study lists 2 primary outcomes in all. 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 NCT02149238, 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 23 Dec 2014.