Effects of Cocoa Procyanidins on Vascular Function

Study Overview
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Brief Summary
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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.

Official Title
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Investigation on the Effects of Cocoa Procyanidins on Vascular Function in Healthy Individuals

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Flavanol and procyanidin supplement
* Dietary Supplement: Procyanidin-containing supplement
* Dietary Supplement: control supplement deprived of flavanols and procyanidins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flavanol and procyanidin supplement<br>Sustained 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<br>* Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)<br>|
| Active Comparator: Procyanidin-containing supplement<br>Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers) | Dietary Supplement: Procyanidin-containing supplement<br>* Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)<br>|
| Placebo Comparator: Flavanols and procyanidins deprived supplement<br>Control supplement deprived of flavanols and procyanidins Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement | Dietary Supplement: control supplement deprived of flavanols and procyanidins<br>* Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flavanols, cocoa procyanidins, vascular function, endothelial function