Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Cocoa Flavanols on Vascular Function in Optimally Treated Coronary Artery Disease Patients: Interaction Between Endothelial Progenitor Cells, Reactivity of Micro- and Macrocirculation
Brief Summary: Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular events in patients with coronary artery disease (CAD). CAD patients also show impaired function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate in adult blood and contribute to endothelial repair. Clinical studies suggest that endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa. Yet, the mechanism is not known. It is also not known whether flavanol-rich cocoa provides an additive, positive effect in patients who are already receiving the maximal recommended therapies for risk factor modification. Therefore, the researchers propose to perform an investigator-initiated, randomized controlled cross-over study administering flavanol-rich cocoa or a placebo for two months in CAD patients on optimal medical therapy. An improvement of endothelial function as measured by flow-mediated dilation (FMD) will be the primary endpoint of this study. The researchers propose to also measure determinants of FMD such as microvascular response, inflammatory markers, metabolites of nitric oxide, as well as the number and function of EPCs in the blood. Importantly, detailed food questionnaires and plasma flavanols/metabolites will help to further support a causal link between flavanol-intake and improved vascular function.


Options:
A: Arm Label: Low- polyphenol diet; Type: OTHER; Interventions: Other: Two portions of fruit and vegetables per day (excluding berries and dark chocolate) | Arm Label: High-polyphenol diet; Type: ACTIVE_COMPARATOR; Interventions: Other: Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate. | Intervention Type: OTHER; Name: Two portions of fruit and vegetables per day (excluding berries and dark chocolate); Assigned to Arm(s): Low- polyphenol diet | Intervention Type: OTHER; Name: Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.; Assigned to Arm(s): High-polyphenol diet
B: Arm Label: Cocoa Flavanol intake escalation; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Mars Cocoa Extract Capsules | Intervention Type: DIETARY_SUPPLEMENT; Name: Mars Cocoa Extract Capsules; Assigned to Arm(s): Cocoa Flavanol intake escalation
C: Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Control breakfast, Other: High glycemic index breakfast, Other: Low glycemic index breakfast | Arm Label: Intervention 1; Type: EXPERIMENTAL; Interventions: Other: Control breakfast, Other: High glycemic index breakfast, Other: Low glycemic index breakfast | Arm Label: Intervention 2; Type: EXPERIMENTAL; Interventions: Other: Control breakfast, Other: High glycemic index breakfast, Other: Low glycemic index breakfast | Intervention Type: OTHER; Name: Control breakfast; Assigned to Arm(s): Control, Intervention 1, Intervention 2 | Intervention Type: OTHER; Name: High glycemic index breakfast; Assigned to Arm(s): Control, Intervention 1, Intervention 2 | Intervention Type: OTHER; Name: Low glycemic index breakfast; Assigned to Arm(s): Control, Intervention 1, Intervention 2
D: Arm Label: Flavanol; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Cocoa Flavanols | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Cocoa Flavanols; Assigned to Arm(s): Flavanol | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D