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Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

Acute Study to Investigate the Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02149238
Acronym
New Drink
Enrollment
36
Registered
2014-05-29
Start date
2011-02-28
Completion date
2014-12-31
Last updated
2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

flavanols, cardiovascular effects, nutrition-nutrition interaction

Brief summary

Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure. However, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.

Interventions

DIETARY_SUPPLEMENTflavanol
DIETARY_SUPPLEMENTmethylxanthine
DIETARY_SUPPLEMENTflavanol + methylxanthine

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy male subjects * \>18 years

Exclusion criteria

* acute inflammation * cardiac arrhythmia * renal failure * heart failure (NYHA II-IV) * diabetes mellitus * CRP \> 1 mg/dl * malignant disease

Design outcomes

Primary

MeasureTime frameDescription
Endothelial function2 hoursFlow mediated dilatation (FMD)
Plasma flavanol metabolites2 hoursMeasured by HPLC

Secondary

MeasureTime frameDescription
Pulse wave velocity2 hoursMeasured by SphygmoCor
Ambulatory blood pressure2 hoursautomatical measurements
Circulation angiogenetic cells2 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026