Intake of Crataegus extract WS® 1442 compared to physical exercise in mildly overweight, healthy volunteers – safety and influence on endothelial function

Aims: Safety and efficacy of Crataegus extract WS^® 1442 have already been demonstrated in patients with NYHA II/III cardiac insufficiency. A pilot study was performed to investigate the safety of two different doses of WS® 1442 in mildly overweight subjects, including preliminary investigations on the influence of the drug on endothelial function and lipid parameters.

Methods: 60 male or female mildly overweight (BMI: 25.0 – 29.9 kg/m²) otherwise healthy volunteers (age range 45 – 75 years) were randomised to receive WS® 1442 450 mg b.i.d., WS® 1442 900 mg b.i.d., light exercise (Nordic Walking, 2 × 30 min/week) or moderate exercise (Nordic Walking, 4 × 45 min/week) for 12 weeks. As exploratory pharmacodynamic outcome, parameters of endothelial function (Reactive Hyperaemia Index [RHI]; Augmentation Index [AI]) and plasma lipids were measured. Furthermore, quantitative measurement of endothelial progenitor cells (EPC) was conducted.

Results: In all groups, subjects with impaired endothelial function at baseline (RHI< 1.67) showed improvements of RHI. Overall, the higher dose of WS® 1442 (900 mg b.i.d.) did not show additional benefit compared to the currently recommended daily dose. An increase in maximal duration of exercise, workload and exercise capacity was only seen in the Nordic walking groups. All reported adverse events were either not or improbably related to the investigational treatments.

Conclusions: WS® 1442 was safe and showed promising effects in slightly overweight, healthy volunteers.