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OpenTrials
Completed

NCT Number: NCT02728466

Effects of Cocoa Procyanidins on Vascular Function

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Procyanidin-containing supplement

Dietary Supplement

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

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

Primary outcomes

  1. Change form Baseline Endothelial function at 1 month

    Time frame: Baseline and 1 month

    Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption on baseline and on 1 month

Secondary outcomes

  1. Plasma flavanol metabolites

    Time frame: Baseline and 1 month

    Measured by high performance liquid chromotography (HPLC) at 2 hours and on 1 month postconsumption

  2. Urinary flavanol metabolites

    Time frame: Baseline and 1 month

    Measured up to 24 hours post consumption on day 1 and 1 month after consumption

  3. Urinary valerolactone metabolites

    Time frame: Baseline and 1 month

    Measured up to 24 hours post consumption on day 1 and 1 month after consumption

Other outcomes

  1. Pulse wave velocity

    Time frame: Baseline and 1 month

    Measured by SphygmoCor on baseline 2 hours postconsumption and on 1 month.

  2. Blood pressure

    Time frame: Baseline and 1 month

    automatical measurements on baseline 2 hours postconsumption and on 1 month

  3. high density lipoproteins (HDL)

    Time frame: Baseline and 1 month

    measured on baseline and after 1 month

  4. low density lipoproteins (LDL)

    Time frame: Baseline and 1 month

    measured on baseline and after 1 month

  5. cholesterol

    Time frame: Baseline and 1 month

    measured on baseline and after 1 month

  6. triglyceride

    Time frame: Baseline and 1 month

    measured on baseline and after 1 month

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2016
Registry last updated
Jun 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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