Effects of Cocoa Procyanidins on Vascular Function

NCT ID: NCT02728466

Last Updated: 2016-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-05-31

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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Flavanol and procyanidin supplement

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

Group Type ACTIVE_COMPARATOR

Flavanol and procyanidin supplement

Intervention Type DIETARY_SUPPLEMENT

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

Procyanidin-containing supplement

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

Group Type ACTIVE_COMPARATOR

Procyanidin-containing supplement

Intervention Type DIETARY_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 Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement

Group Type PLACEBO_COMPARATOR

control supplement deprived of flavanols and procyanidins

Intervention Type DIETARY_SUPPLEMENT

Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement

Interventions

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Flavanol and procyanidin supplement

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

Intervention Type DIETARY_SUPPLEMENT

Procyanidin-containing supplement

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

Intervention Type DIETARY_SUPPLEMENT

control 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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Kardiologie, Pneumologie und Angiologie

Division of Cardiology, Pulmonary Diseases, Vascular Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Heiß, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Malte Kelm, Prof. MD

Role: STUDY_CHAIR

Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Locations

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

Düsseldorf, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 30358831 (View on PubMed)

Other Identifiers

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12-018

Identifier Type: OTHER

Identifier Source: secondary_id

Cocoa procyanidins

Identifier Type: -

Identifier Source: org_study_id

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