Effects of Cocoa Procyanidins on Vascular Function

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Flavanol and procyanidin supplement; Dietary Supplement: Procyanidin-containing supplement; Dietary Supplement: control supplement deprived of flavanols and procyanidins

• Registration Number: NCT02728466
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flavanol and procyanidin supplement	Flavanol and procyanidin supplement	Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
Procyanidin-containing supplement	Procyanidin-containing supplement	Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
Flavanols and procyanidins deprived supplement	control supplement deprived of flavanols and procyanidins	Control supplement deprived of flavanols and procyanidins Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Urinary valerolactone metabolites	Baseline and 1 month	Measured up to 24 hours post consumption on day 1 and 1 month after consumption
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

Trial Locations

Locations (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf; 🇩🇪 Duesseldorf, Germany