Cardiovascular DiseasesPhase 1NCT01639781
Age-dependent Effects of Flavanols on Vascular Status
A Phase 1 study testing Flavanol rich 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 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Flavanol rich intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Aug 2014
- Phase
- Phase 1
- 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male participants between 18-35 years
- healthy male participants between 50-80 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, North Rhine-Westphalia, 40225
About this study
Official title: Age-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status After Acute and Chronic Application.
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. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.
- Conditions
- Cardiovascular Diseases
- Being tested
- Flavanol rich intervention, Flavanol free control
- Keywords
- flavanols, age 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 drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks
Flavanol free controlDietary supplement
Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| flavanol rich intervention | Active comparator | flavanol rich drink Receives: Dietary Supplement: Flavanol rich intervention |
| flavanol free intervention | Placebo comparator | flavanol free drink Receives: Dietary Supplement: Flavanol free control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Flow mediated dilatation (FMD)
Measured: change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14
Secondary outcomes (8)
Plasma flavanol metabolites
Measured by HPLC
Measured: analysis of metabolites between first treatment at day 0 and after last treatment at day 14
Ambulatory blood pressure
automatical measurements
Measured: blood pressure at day 0 and at day 14
Pulse wave velocity
Measured by SphygmoCor
Measured: 14 days
Microvascular function
Measured by Laserdoppler perfusion imaging (LDPI)
Measured: 14 days
Augmentation index
Measured by SphygmoCor
Measured: 14 days
Heart rate
Measured by ECG
Measured: 14 days
Erythrocyte deformability
Measured by Laser-assisted Optical Rotation Cell Analyzer (LORCA)
Measured: 14 days
NO bioavailability
Measured by CLD
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2014
- Study completionAug 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading
- 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
- NCT01639781
- Sponsor's protocol ID
- AGE-111-CH
- Other IDs
- FLA-111-CH
- Status last verified
- Dec 2014
- First submitted
- 6 Jun 2012
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Heiss C, Sansone R, Karimi H, Krabbe M, Schuler D, Rodriguez-Mateos A, Kraemer T, Cortese-Krott MM, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M; FLAVIOLA Consortium, European Union 7th Framework Program. Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial. Age (Dordr). 2015 Jun;37(3):9794. doi: 10.1007/s11357-015-9794-9. Epub 2015 May 27.
PubMed 26013912
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status After Acute and Chronic Application.
- ClinicalTrials.gov ID
- NCT01639781
- Acronym / sponsor ID
- AGE-111-CH
- Conditions
- Cardiovascular Diseases
- Keywords
- flavanols, age related cardiovascular effects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- University of Reading
- Study start
- Nov 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Jul 2012 (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. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flavanol rich intervention | Active comparator | Dietary Supplement: Flavanol rich interventionflavanol rich drink |
| flavanol free intervention | Placebo comparator | Dietary Supplement: Flavanol free controlflavanol free drink |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy male participants between 18-35 years
- healthy male participants between 50-80 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 drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks | Dietary supplement | flavanol rich intervention |
| Flavanol free controlCalorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks | Dietary supplement | flavanol free intervention |
Primary outcome
Endothelial function
Time frame: change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14
Flow mediated dilatation (FMD)
8 secondary outcomes
Plasma flavanol metabolites
Time frame: analysis of metabolites between first treatment at day 0 and after last treatment at day 14
Ambulatory blood pressure
Time frame: blood pressure at day 0 and at day 14
Pulse wave velocity
Time frame: 14 days
Microvascular function
Time frame: 14 days
Augmentation index
Time frame: 14 days
Heart rate
Time frame: 14 days
Erythrocyte deformability
Time frame: 14 days
NO bioavailability
Time frame: 14 days
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 Dec 2014.
- Derived from this study: PubMed 26013912Heiss C, Sansone R, Karimi H, Krabbe M, Schuler D, Rodriguez-Mateos A, Kraemer T, Cortese-Krott MM, Kuhnle GG, Spencer JP, Schroeter H, Merx MW, Kelm M; FLAVIOLA Consortium, European Union 7th Framework Program. Impact of cocoa flavanol intake on age-dependent vascular stiffness in healthy men: a randomized, controlled, double-masked trial. Age (Dordr). 2015 Jun;37(3):9794. doi: 10.1007/s11357-015-9794-9. Epub 2015 May 27.
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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 Phase 1 study testing Flavanol rich 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 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14). 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 NCT01639781, 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 16 Dec 2014.