Effects of Cocoa Procyanidins on Vascular Function

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

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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