Atlantia can provide quality assured data on cardiovascular health parameters that meet product efficacy and regulatory needs.
For those purposes, structural and functional properties of the vascular system can be evaluated in a non-invasive and subject friendly fashion by means of high-resolution ultrasound imaging and advanced multi-arterial blood-pressure measurements. The arterial function measurements (brachial flow mediated dilatation, pulse wave velocity, peripheral and central blood pressures) and the arterial wall structure measurements (carotid arterial wall thickness and elasticity) can provide complementary quality assured cardiovascular health data on the benefits of nutrient and life-style interventions.
Of particular interest is arterial endothelial function testing, as assessed by brachial artery FMD. These validated sensitive measurements are of great value in nutraceutical trials as product efficacy and cardiovascular health claims can be evaluated within a relatively short time period and in small study samples. Endothelial function assessments are patient friendly and results are well received by regulatory authorities like the EFSA and the FDA.
How are endothelial function tests done?
The endothelium is the interactive inner layer of arteries. It plays a pivotal role in cardiovascular health.
In an endothelial function test the brachial artery is visualized by high resolution ultrasound imaging. The arterial blood flow is increased after release upon 1 minute occlusion of a forearm blood pressure cuff. The increased blood flow activates the endothelial cells of the inner lining (or intima) of the arterial wall to release nitric oxide (NO). NO will diffuse into the muscular layer of the artery and induce muscle relaxation and its associated widening (dilatation) of the arterial lumen diameter. This diameter change can be measured with ultrasound imaging. The ECG-triggered clips are analyzed off-line and independently from the sonographers by a specialized core lab. For image analysis automated edge detection software is used. The software follows the endothelial contours to compute arterial lumen diameter change between resting and post cuff-release. The % lumen change is defined as flow mediated dilatation and is depicted in the graph.
Typically vital endothelial cells in healthy individuals will have a better NO-release, and hence a better endothelial function (around 10 – 15%) than in those individuals with cardiovascular risk factors like smoking, hypertension and dyslipidemia (0-5%). As represented by a higher (healthier) FMD, efficacious nutraceuticals improve endothelial function (e.g. increase FMD) and are of benefit on cardiovascular health. Arterial diameter changes in FMD measurements are minute and methodology is challenging. However by implementation of a rigorous training/certification and quality control program Atlantia has successfully applied endothelial function measurements as a sensitive and highly reproducible tool in cardiovascular health studies.
The Atlantia team works closely with Dr. Eric de Groot in this specific area, particularly in the design, image analysis (including 0A/OC) of cardiovascular studies with FMD as an endpoint.