Clinical Research
Vascular Function
Sustained Benefits in Vascular Function Through Flavanol-Containing Cocoa in Medicated Diabetic Patients: A Double-Masked, Randomized, Controlled Trial

https://doi.org/10.1016/j.jacc.2008.01.059Get rights and content
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Objectives

Our goal was to test feasibility and efficacy of a dietary intervention based on daily intake of flavanol-containing cocoa for improving vascular function of medicated diabetic patients.

Background

Even in fully medicated diabetic patients, overall prognosis is unfavorable due to deteriorated cardiovascular function. Based on epidemiological data, diets rich in flavanols are associated with a reduced cardiovascular risk.

Methods

In a feasibility study with 10 diabetic patients, we assessed vascular function as flow-mediated dilation (FMD) of the brachial artery, plasma levels of flavanol metabolites, and tolerability after an acute, single-dose ingestion of cocoa, containing increasing concentrations of flavanols (75, 371, and 963 mg). In a subsequent efficacy study, changes in vascular function in 41 medicated diabetic patients were assessed after a 30-day, thrice-daily dietary intervention with either flavanol-rich cocoa (321 mg flavanols per dose) or a nutrient-matched control (25 mg flavanols per dose). Both studies were undertaken in a randomized, double-masked fashion. Primary and secondary outcome measures included changes in FMD and plasma flavanol metabolites, respectively.

Results

A single ingestion of flavanol-containing cocoa was dose-dependently associated with significant acute increases in circulating flavanols and FMD (at 2 h: from 3.7 ± 0.2% to 5.5 ± 0.4%, p < 0.001). A 30-day, thrice-daily consumption of flavanol-containing cocoa increased baseline FMD by 30% (p < 0.0001), while acute increases of FMD upon ingestion of flavanol-containing cocoa continued to be manifest throughout the study. Treatment was well tolerated without evidence of tachyphylaxia. Endothelium-independent responses, blood pressure, heart rate, and glycemic control were unaffected.

Conclusions

Diets rich in flavanols reverse vascular dysfunction in diabetes, highlighting therapeutic potentials in cardiovascular disease.

Abbreviations and Acronyms

FMD
flow-mediated dilation
GTN
glycerol trinitrate
NO
nitric oxide

Cited by (0)

Mars Inc., McLean, Virginia supported this study with an unrestricted grant. Drs. Kelm (Ke 405/5-1), Rassaf (Ra 969/4-1), and Merx (ME 1821/3-1) are supported by the Deutsche Forschungsgemeinschaft, Bonn, Germany. Drs. Balzer and Rassaf are funded by an intramural funding program of the University Hospital RWTH Aachen (START-Verbundantrag: Kardiovaskuläre Dysfunktion durch Kalk und Niereninsuffizienz, Teilprojekt P5). Dr. Lauer is supported by the Hans und Gertie Fischer-Stiftung, Essen, Germany, and Dr. Heiss is supported by an award from the American Heart Association (0525078Y). Dr. Schroeter is employed by Mars Symbioscience, a division of Mars Inc. Mars Inc. provided the instant cocoa beverage powder for the preparation of cocoa drinks. Furthermore, Mars Inc. had no role in the design, conduct, and analysis of the study. Drs. Balzer and Rassaf contributed equally to this work.