British Journal of Nutrition

  • British Journal of Nutrition / Volume 114 / Issue 08 / October 2015, pp 1246-1255
  • Copyright © The Authors 2015 This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (, which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
  • DOI: (About DOI), Published online: 09 September 2015

Full Papers

Human and Clinical Nutrition

Cocoa flavanol intake improves endothelial function and Framingham Risk Score in healthy men and women: a randomised, controlled, double-masked trial: the Flaviola Health Study

Roberto Sansonea1, Ana Rodriguez-Mateosa1, Jan Heuela1, David Falka1, Dominik Schulera1, Rabea Wagstaffa1, Gunter G. C. Kuhnlea2, Jeremy P. E. Spencera2, Hagen Schroetera3, Marc W. Merxa1, Malte Kelma1a4, Christian Heissa1 c1 id1 and for the Flaviola Consortium, European Union 7th Framework Program

a1 Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, University Duesseldorf, 40225 Duesseldorf, Germany

a2 Department of Food and Nutritional Sciences, University of Reading, Reading, UK

a3 Mars Inc., McLean, VA, USA

a4 Cardiovascular Research Institute Duesseldorf, Medical Faculty, University Duesseldorf, 40225 Duesseldorf, Germany



Cocoa flavanol (CF) intake improves endothelial function in patients with cardiovascular risk factors and disease. We investigated the effects of CF on surrogate markers of cardiovascular health in low risk, healthy, middle-aged individuals without history, signs or symptoms of CVD. In a 1-month, open-label, one-armed pilot study, bi-daily ingestion of 450 mg of CF led to a time-dependent increase in endothelial function (measured as flow-mediated vasodilation (FMD)) that plateaued after 2 weeks. Subsequently, in a randomised, controlled, double-masked, parallel-group dietary intervention trial ( NCT01799005), 100 healthy, middle-aged (35–60 years) men and women consumed either the CF-containing drink (450 mg) or a nutrient-matched CF-free control bi-daily for 1 month. The primary end point was FMD. Secondary end points included plasma lipids and blood pressure, thus enabling the calculation of Framingham Risk Scores and pulse wave velocity. At 1 month, CF increased FMD over control by 1·2 % (95 % CI 1·0, 1·4 %). CF decreased systolic and diastolic blood pressure by 4·4 mmHg (95 % CI 7·9, 0·9 mmHg) and 3·9 mmHg (95 % CI 6·7, 0·9 mmHg), pulse wave velocity by 0·4 m/s (95 % CI 0·8, 0·04 m/s), total cholesterol by 0·20 mmol/l (95 % CI 0·39, 0·01 mmol/l) and LDL-cholesterol by 0·17 mmol/l (95 % CI 0·32, 0·02 mmol/l), whereas HDL-cholesterol increased by 0·10 mmol/l (95 % CI 0·04, 0·17 mmol/l). By applying the Framingham Risk Score, CF predicted a significant lowering of 10-year risk for CHD, myocardial infarction, CVD, death from CHD and CVD. In healthy individuals, regular CF intake improved accredited cardiovascular surrogates of cardiovascular risk, demonstrating that dietary flavanols have the potential to maintain cardiovascular health even in low-risk subjects.

(Received March 01 2015)

(Revised May 31 2015)

(Accepted June 22 2015)

(Online publication September 09 2015)

Key words

  • Flow-mediated dilation;
  • Cardiovascular health;
  • Flavanols;
  • Blood pressure


  • BP:blood pressure;
  • CF:cocoa flavanol;
  • DBP;
  • diastolic blood pressure;
  • FMD:flow-mediated dilation;
  • PWV:pulse wave velocity;
  • SBP:systolic blood pressure


c1 Corresponding author: Dr C. Heiss, fax +49 211 811 8812, email