Effects of Cocoa Procyanidins on Vascular Function

NCT02728466 | Completed

• 2 other identifiers: Cocoa procyanidins12-018
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

flavanols; cocoa procyanidins; vascular function; endothelial function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Plasma flavanol metabolites

  Baseline and 1 month

• Urinary flavanol metabolites

  Baseline and 1 month

• Urinary valerolactone metabolites

  Baseline and 1 month

Other Outcomes (6)

• Pulse wave velocity

  Baseline and 1 month

• Blood pressure

  Baseline and 1 month

• high density lipoproteins (HDL)

  Baseline and 1 month

Study Arms (3)

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)

Dietary Supplement: Flavanol and procyanidin supplement

Procyanidin-containing supplement

ACTIVE COMPARATOR

Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)

Dietary Supplement: Procyanidin-containing supplement

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

Dietary Supplement: control supplement deprived of flavanols and procyanidins

Interventions

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)

Flavanol and procyanidin supplement

Procyanidin-containing supplement DIETARY_SUPPLEMENT

Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)

Procyanidin-containing supplement

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

Flavanols and procyanidins deprived supplement

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male subjects (no clinical signs or symptoms of cardiovascular disease)
• \>18 years, \<35 years

You may not qualify if:

• cardiovascular disease
• acute inflammation
• cardiac arrhythmia
• renal failure
• heart failure (NYHA II-IV)
• diabetes mellitus
• C-reactive protein \> 1 mg/dl
• malignant disease

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Related Publications (1)

• 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.

  PMID: 30358831 DERIVED

MeSH Terms

Interventions

Proanthocyanidins

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tannins; Biopolymers; Polymers; Macromolecular Substances

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: April 5, 2016
• Study Start: October 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 22, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)