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

Abstract

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 (Clinicaltrials.gov: 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.

Keywords: BP blood pressure; Blood pressure; CF cocoa flavanol; Cardiovascular health; DBP; FMD flow-mediated dilation; Flavanols; Flow-mediated dilation; PWV pulse wave velocity; SBP systolic blood pressure; diastolic blood pressure.

Figures

Fig. 1

(a) Study flow (CONSORT diagram) and (b) study protocol of the randomised controlled study. BID, twice daily; FMD, flow-mediated dilation; PWV, pulse wave velocity; AIX, augmentation index.

Fig. 2

Time course of flow-mediated dilation (FMD) during the open-label pilot study. Measurements were taken before (0 h) and at 0, 1 and 2 h after ingestion of the first intervention drink on days 1, 7, 14, 21 and 28 while consuming the drink twice per d (n 5). Ingestion of a single test drink led to an ‘acute’ increase in FMD on days 1 and 7 (A). Although the FMD value as measured after repeated consumption of the drink increased the ‘chronic effect’ (B), ‘acute-on-chronic’ improvements were no longer statistically significant at days 14, 21 and 28 during daily consumption (C). * P<0·05v. 0 h at the same day, respectively, †P<0·05 v. 0 h at day 1. Values are means with their standard errors represented by vertical bars.