Healthy
Conditions
Keywords
flavanols, cocoa procyanidins, vascular function, endothelial function
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTFlavanol and procyanidin supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
DIETARY_SUPPLEMENTProcyanidin-containing supplement
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
DIETARY_SUPPLEMENTcontrol supplement deprived of flavanols and procyanidins
Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy male subjects (no clinical signs or symptoms of cardiovascular disease) * \>18 years, \<35 years
Exclusion criteria
* cardiovascular disease * acute inflammation * cardiac arrhythmia * renal failure * heart failure (NYHA II-IV) * diabetes mellitus * C-reactive protein \> 1 mg/dl * malignant disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change form Baseline Endothelial function at 1 month | Baseline and 1 month | Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption on baseline and on 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma flavanol metabolites | Baseline and 1 month | Measured by high performance liquid chromotography (HPLC) at 2 hours and on 1 month postconsumption |
| Urinary flavanol metabolites | Baseline and 1 month | Measured up to 24 hours post consumption on day 1 and 1 month after consumption |
| Urinary valerolactone metabolites | Baseline and 1 month | Measured up to 24 hours post consumption on day 1 and 1 month after consumption |
Other
| Measure | Time frame | Description |
|---|---|---|
| cholesterol | Baseline and 1 month | measured on baseline and after 1 month |
| Pulse wave velocity | Baseline and 1 month | Measured by SphygmoCor on baseline 2 hours postconsumption and on 1 month. |
| triglyceride | Baseline and 1 month | measured on baseline and after 1 month |
| Blood pressure | Baseline and 1 month | automatical measurements on baseline 2 hours postconsumption and on 1 month |
| high density lipoproteins (HDL) | Baseline and 1 month | measured on baseline and after 1 month |
| low density lipoproteins (LDL) | Baseline and 1 month | measured on baseline and after 1 month |
Countries
Germany
Outcome results
None listed