Clinical trial NCT02728466: Effects of Cocoa Procyanidins on Vascular Function
Official title: Investigation on the Effects of Cocoa Procyanidins on Vascular Function in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: flavanols
cocoa procyanidins
vascular function
endothelial function
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change form Baseline Endothelial function at 1 month
timeFrame: Baseline and 1 month
Secondary outcomes:
measure: Plasma flavanol metabolites
timeFrame: Baseline and 1 month
measure: Urinary flavanol metabolites
timeFrame: Baseline and 1 month
measure: Urinary valerolactone metabolites
timeFrame: Baseline and 1 month
Other outcomes:
measure: Pulse wave velocity
timeFrame: Baseline and 1 month
measure: Blood pressure
timeFrame: Baseline and 1 month
measure: high density lipoproteins (HDL)
timeFrame: Baseline and 1 month
measure: low density lipoproteins (LDL)
timeFrame: Baseline and 1 month
measure: cholesterol
timeFrame: Baseline and 1 month
measure: triglyceride
timeFrame: Baseline and 1 month
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Study officials:
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
name: Christian Heiß, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
name: Malte Kelm, Prof. MD
role: STUDY_CHAIR
References:
citation: 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.