Effects of Cocoa Procyanidins on Vascular Function

H

Heinrich-Heine University, Duesseldorf

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Procyanidin-containing supplement
Dietary Supplement: Flavanol and procyanidin supplement
Dietary Supplement: control supplement deprived of flavanols and procyanidins

Study type

Interventional

Funder types

Other

Identifiers

NCT02728466
12-018
Cocoa procyanidins

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 3 patient groups, including a placebo group

Flavanol and procyanidin supplement
Active Comparator group
Description:
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
Treatment:
Dietary Supplement: Flavanol and procyanidin supplement
Procyanidin-containing supplement
Active Comparator group
Description:
Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
Treatment:
Dietary Supplement: Procyanidin-containing supplement
Flavanols and procyanidins deprived supplement
Placebo Comparator group
Description:
Control supplement deprived of flavanols and procyanidins Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement
Treatment:
Dietary Supplement: control supplement deprived of flavanols and procyanidins

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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