Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT07265869
Brief Summary:
Sitting time is high in older adults and has been shown to temporarily impair endothelial function and blood pressure. Flavanols, plant-derived compounds, acutely enhance endothelial function and reduce Blood pressure in older adults. The aim of this study is to investigate whether acute ingestion of cocoa flavanols can improve peripheral endothelial function and blood pressure during prolonged sitting in healthy older adults.
In a randomised, double-blinded, cross-over, placebo-controlled human study, 20 healthy older adults will consume either a high-flavanol (695 mg) or low-flavanol (5.6 mg) cocoa beverage immediately before a 2-hour sitting bout. Flow-mediated dilation (FMD) of the superficial femoral (SFA; primary outcome) and brachial (BA) arteries, and blood pressure, were assessed before and after sitting. Microvasculature haemodynamics were assessed in the gastrocnemius before, during, and after sitting. It is hypothesized that the high flavanol cocoa will prevent declines in brachial and superficial femoral Flow-mediated dilatation post sitting.
Detailed Description:
Older individuals are estimated to spend more than 10 hours in their waking day in sedentary activities , which can include sitting bouts lasting up to 5.4 hours/day . Greater sedentary time was found to be associated with a significantly increased risk of cardiovascular diseases and all-cause mortality. Several experimental studies have shown that even just one isolated episode of prolonged sitting (from 1 to 6 hours) has detrimental effects on human endothelial function, as measured by flow-mediated dilation (FMD).
Flavonoid-rich foods are typically consumed in high amounts in cardioprotective diets, with evidence from both observational and Randomised Controlled Trials showing flavonoids to improve biomarkers of cardiovascular health. Flavanols, a sub-group of flavonoids present in unprocessed cocoa, have been extensively shown to act quickly within the vasculature, improving both brachial Flow-mediated dilatation and lower-limb common femoral artery (CFA) Flow-mediated dilatation within 2 hours of intake in older adults.
The aim of the current study is to examine whether acute consumption of cocoa flavanols prior to a 2-hour bout of uninterrupted sitting can be beneficial in improving endothelial function (as measured by Flow mediated dilatation) in the upper-limb Brachial Artery (BA) and lower-limb Superficial Femoral Artery (SFA) in older adults, as well as downstream, muscle microvascular function. We will further investigate whether cocoa flavanols can prevent sitting-induced increases in blood pressure in older adults. We hypothesise that cocoa flavanols would be effective at rescuing upper- and lower-limb Flow-mediated dilatation and improve blood pressure during uninterrupted sitting in older age
Study:
NCT07265869
Study Brief:
Protocol Section:
NCT07265869