Cardiovascular DiseasesNCT02147223
Sex-dependent Effects of Flavanols on Vascular Status
A study testing Flavanol rich intervention and Flavanol free intervention 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 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Flavanol rich intervention and Flavanol free intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Nov 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy post-menopausal femal subjects (>50 years)
- healthy male subjects (>50 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: Sex-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status
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. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.
- Conditions
- Cardiovascular Diseases
- Being tested
- Flavanol rich intervention, Flavanol free intervention
- Keywords
- flavanols, sex-related cardiovascular effects
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanol rich interventionDietary supplement
Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)
Flavanol free interventionDietary supplement
Calorically, micro- and macronutrient matched control product free of flavanols
| Study group | Role | What they receive |
|---|---|---|
| Flavanol rich product A | Active comparator | 250 mg flavanols Receives: Dietary Supplement: Flavanol rich intervention; Dietary Supplement: Flavanol free intervention |
| Flavanol rich product B | Active comparator | 500 mg flavanols Receives: Dietary Supplement: Flavanol rich intervention; Dietary Supplement: Flavanol free intervention |
| Flavanol rich product C | Active comparator | 750 mg flavanols Receives: Dietary Supplement: Flavanol rich intervention; Dietary Supplement: Flavanol free intervention |
| Flavanol free product | Placebo comparator | flavanol free Receives: Dietary Supplement: Flavanol rich intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change of Flow-mediated Vasodilation (FMD)
Measured: 2 hours
Secondary outcomes (5)
Pulse wave velocity
Measured by SphygmoCor
Measured: 2 hours
Augmentation index
Measured by SphygmoCor
Measured: 2 hours
Ambulatory blood pressure
automatical measurements
Measured: 2 hours
Plasma flavanol metabolites
Measured by HPLC
Measured: 2 hours
laboratory safety parameters
blood/urine samples for safety assessment (haematology, biochemistry, and urinalysis)
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 posted26 May 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 24 participants (actual)
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 MedicineAna Rodriguez Mateos, PhD, 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
- NCT02147223
- Sponsor's protocol ID
- BRANDED
- Status last verified
- Apr 2015
- First submitted
- 22 May 2014
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status
- ClinicalTrials.gov ID
- NCT02147223
- Acronym / sponsor ID
- BRANDED
- Conditions
- Cardiovascular Diseases
- Keywords
- flavanols, sex-related cardiovascular effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 26 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. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flavanol rich product A | Active comparator | Dietary Supplement: Flavanol rich intervention, Dietary Supplement: Flavanol free intervention250 mg flavanols |
| Flavanol rich product B | Active comparator | Dietary Supplement: Flavanol rich intervention, Dietary Supplement: Flavanol free intervention500 mg flavanols |
| Flavanol rich product C | Active comparator | Dietary Supplement: Flavanol rich intervention, Dietary Supplement: Flavanol free intervention750 mg flavanols |
| Flavanol free product | Placebo comparator | Dietary Supplement: Flavanol rich interventionflavanol free |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy post-menopausal femal subjects (>50 years)
- healthy male subjects (>50 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 rich interventionFlavanol intervention products (250 mg, 500 mg and 750 mg flavanols) | Dietary supplement | Flavanol free product, Flavanol rich product A, Flavanol rich product B, Flavanol rich product C |
| Flavanol free interventionCalorically, micro- and macronutrient matched control product free of flavanols | Dietary supplement | Flavanol rich product A, Flavanol rich product B, Flavanol rich product C |
Primary outcome
Absolute change of Flow-mediated Vasodilation (FMD)
Time frame: 2 hours
5 secondary outcomes
Pulse wave velocity
Time frame: 2 hours
Augmentation index
Time frame: 2 hours
Ambulatory blood pressure
Time frame: 2 hours
Plasma flavanol metabolites
Time frame: 2 hours
laboratory safety parameters
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 16 Apr 2015.
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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
Ana Rodriguez Mateos, PhD 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 rich intervention and Flavanol free intervention 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 16 Apr 2015. 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. 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?
Absolute change of Flow-mediated Vasodilation (FMD) (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2015.