Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 12-018 | Other Identifier | CTSU |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Procyanidin-containing supplement | Active Comparator | Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavanol and procyanidin supplement | Dietary Supplement | Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma flavanol metabolites | Measured by high performance liquid chromotography (HPLC) at 2 hours and on 1 month postconsumption | Baseline and 1 month |
| Urinary flavanol metabolites | Measured up to 24 hours post consumption on day 1 and 1 month after consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse wave velocity | Measured by SphygmoCor on baseline 2 hours postconsumption and on 1 month. | Baseline and 1 month |
| Blood pressure | automatical measurements on baseline 2 hours postconsumption and on 1 month |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian Heiß, MD | Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf | Principal Investigator |
| Malte Kelm, Prof. MD | Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf | Düsseldorf | 40225 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30358831 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D044945 | Proanthocyanidins |
| ID | Term |
|---|---|
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procyanidin-containing supplement | Dietary Supplement | Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers) |
|
| control supplement deprived of flavanols and procyanidins | Dietary Supplement | Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement |
|
| Baseline and 1 month |
| Urinary valerolactone metabolites | Measured up to 24 hours post consumption on day 1 and 1 month after consumption | Baseline and 1 month |
| Baseline and 1 month |
| high density lipoproteins (HDL) | measured on baseline and after 1 month | Baseline and 1 month |
| low density lipoproteins (LDL) | measured on baseline and after 1 month | Baseline and 1 month |
| cholesterol | measured on baseline and after 1 month | Baseline and 1 month |
| triglyceride | measured on baseline and after 1 month | Baseline and 1 month |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013634 | Tannins |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |