HealthyNCT02728466
Effects of Cocoa Procyanidins on Vascular Function
A study testing Flavanol and procyanidin supplement and Procyanidin-containing supplement in people with Healthy, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
There is a question regarding the role of higher flavanol oligomers (procyanidins) and of intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are absorbed in the small intestine and enter circulation. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Flavanol and procyanidin supplement and Procyanidin-containing supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to May 2016
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects (no clinical signs or symptoms of cardiovascular disease)
- >18 years, <35 years
Who cannot join
- cardiovascular disease
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
- diabetes mellitus
- C-reactive protein > 1 mg/dl
- malignant disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Düsseldorf, 40225
About this study
Official title: Investigation on the Effects of Cocoa Procyanidins on Vascular Function in Healthy Individuals
There is a question regarding the role of higher flavanol oligomers (procyanidins) and of intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are absorbed in the small intestine and enter circulation. Higher oligomers (procyanidins) are not absorbed and are catabolized by the colonic microflora. The catabolites enter the circulation. Phenolic acids and valerolactones represent a significant proportion of these catabolites, reaching peak concentrations in the order of 6-10 h post ingestion. The vascular effects of these colonic microbiome-derived flavanol derivatives have not been studied so far. The purpose of the study is to determine the timecourse of endothelial function along with flavanol catabolites \& metabolites during acute, sustained, and acute on sustained ingestion of procyanidins as compared to previously used flavanol interventions, and flavanol free control.
- Conditions
- Healthy
- Being tested
- Flavanol and procyanidin supplement, Procyanidin-containing supplement, control supplement deprived of flavanols and procyanidins
- Keywords
- flavanols, cocoa procyanidins, vascular function, endothelial function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavanol and procyanidin supplementDietary supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
Procyanidin-containing supplementDietary supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
control supplement deprived of flavanols and procyanidinsDietary supplement
Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement
| Study group | Role | What they receive |
|---|---|---|
| Flavanol and procyanidin supplement | Active comparator | Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers) Receives: Dietary Supplement: Flavanol and procyanidin supplement |
| Procyanidin-containing supplement | Active comparator | Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers) Receives: Dietary Supplement: Procyanidin-containing supplement |
| Flavanols and procyanidins deprived supplement | Placebo comparator | Control supplement deprived of flavanols and procyanidins Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement Receives: Dietary Supplement: control supplement deprived of flavanols and procyanidins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change form Baseline Endothelial function at 1 month
Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption on baseline and on 1 month
Measured: Baseline and 1 month
Secondary outcomes (3)
Plasma flavanol metabolites
Measured by high performance liquid chromotography (HPLC) at 2 hours and on 1 month postconsumption
Measured: Baseline and 1 month
Urinary flavanol metabolites
Measured up to 24 hours post consumption on day 1 and 1 month after consumption
Measured: Baseline and 1 month
Urinary valerolactone metabolites
Measured up to 24 hours post consumption on day 1 and 1 month after consumption
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionMay 2016
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 HealthyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 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 Medicine, University Hospital DuesseldorfMalte Kelm, Prof. MD, Study chair, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728466
- Sponsor's protocol ID
- Cocoa procyanidins
- Other IDs
- 12-018
- Status last verified
- Jun 2016
- First submitted
- 9 Mar 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rodriguez-Mateos A, Weber T, Skene SS, Ottaviani JI, Crozier A, Kelm M, Schroeter H, Heiss C. Assessing the respective contributions of dietary flavanol monomers and procyanidins in mediating cardiovascular effects in humans: randomized, controlled, double-masked intervention trial. Am J Clin Nutr. 2018 Dec 1;108(6):1229-1237. doi: 10.1093/ajcn/nqy229.
PubMed 30358831
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Effects of Cocoa Procyanidins on Vascular Function in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02728466
- Acronym / sponsor ID
- Cocoa procyanidins
- Conditions
- Healthy
- Keywords
- flavanols, cocoa procyanidins, vascular function, endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Apr 2016 (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.
There is a question regarding the role of higher flavanol oligomers (procyanidins) and of intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are absorbed in the small intestine and enter circulation. Higher oligomers (procyanidins) are not absorbed and are catabolized by the colonic microflora. The catabolites enter the circulation. Phenolic acids and valerolactones represent a significant proportion of these catabolites, reaching peak concentrations in the order of 6-10 h post ingestion. The vascular effects of these colonic microbiome-derived flavanol derivatives have not been studied so far. The purpose of the study is to determine the timecourse of endothelial function along with flavanol catabolites \& metabolites during acute, sustained, and acute on sustained ingestion of procyanidins as compared to previously used flavanol interventions, and flavanol free control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flavanol and procyanidin supplement | Active comparator | Dietary Supplement: Flavanol and procyanidin supplementSustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers) |
| Procyanidin-containing supplement | Active comparator | Dietary Supplement: Procyanidin-containing supplementSustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers) |
| Flavanols and procyanidins deprived supplement | Placebo comparator | Dietary Supplement: control supplement deprived of flavanols and procyanidinsControl supplement deprived of flavanols and procyanidins Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy male subjects (no clinical signs or symptoms of cardiovascular disease)
- >18 years, <35 years
Key exclusion criteria (8 listed)
- cardiovascular disease
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
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 and procyanidin supplementSustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers) | Dietary supplement | Flavanol and procyanidin supplement |
| Procyanidin-containing supplementSustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers) | Dietary supplement | Procyanidin-containing supplement |
| control supplement deprived of flavanols and procyanidinsPlacebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement | Dietary supplement | Flavanols and procyanidins deprived supplement |
Primary outcome
Change form Baseline Endothelial function at 1 month
Time frame: Baseline and 1 month
Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption on baseline and on 1 month
3 secondary outcomes
Plasma flavanol metabolites
Time frame: Baseline and 1 month
Urinary flavanol metabolites
Time frame: Baseline and 1 month
Urinary valerolactone metabolites
Time frame: Baseline and 1 month
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 22 Jun 2016.
- Derived from this study: PubMed 30358831Rodriguez-Mateos A, Weber T, Skene SS, Ottaviani JI, Crozier A, Kelm M, Schroeter H, Heiss C. Assessing the respective contributions of dietary flavanol monomers and procyanidins in mediating cardiovascular effects in humans: randomized, controlled, double-masked intervention trial. Am J Clin Nutr. 2018 Dec 1;108(6):1229-1237. doi: 10.1093/ajcn/nqy229.
- Individual participant dataSharing planned: No
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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, University Hospital Duesseldorf
Malte Kelm, Prof. MD study chair
Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
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 and procyanidin supplement and Procyanidin-containing supplement in people with Healthy, 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 8 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 22 Jun 2016. 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?
Change form Baseline Endothelial function at 1 month (time frame: Baseline and 1 month). 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 NCT02728466, 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 22 Jun 2016; AzTrials last refreshed its copy on 4 Nov 2026.