Assessing FMD in overweight adults

Executive Summary This case study presents a human clinical study designed and conducted at our Cork Facility in Ireland. The sponsor needed a trusted research partner to recruit 80 healthy overweight volunteers and asse s s the efficacy of their investigational product versus placebo on FMD. About the Sponsor Endothelial function (EF) plays an important role in cardiovascular health. Impaired EF is a prominent health concern, as it typically contributes tocardiovasculardisease (CVD), i.e., hypertension, atherosclerosis, or myocardial infarction.

Atlantia was aware of the importance of the use of non-invasive techniques when assessing EF. It would be a critical factor when the study would be presented to the appropriated Ethics Committee following ICH GCP standards.

In an aging population, the high prevalence, increasing incidence, and alarming global number of deaths Year on Year due to CVD demonstrate the importance of counterbalancing CVD with the development of innovative preventive strategies integrated in everyday life. Furthermore, it is well known that clinical states of insulin resistance, including obesity, metabolic syndrome, and diabetes mellitus, are associated with impaired endothelium- dependent vasodilation. Based on this knowledge and considering the large intake of high-GI foods that characterizes today’s Western diet, low-GI foods might be effective in preventing ED. The sponsor, an ingredient producer company highly committed to nutrition research, has worked to develop a low-GI carbohydrate which can act as a sugar replacer Their investigational product, is a functional ingredient, which may contribute to improved cardiovascular health. Based on that hypothesis they understood that further clinical studies were needed in this field.

Challenges and Objectives

The main research objectives of this study were:

• To assess the effect of investigational product, relative to placebo, on change in postprandial flow mediated dilation (FMD). • To investigate the effect of investigational product, relative to placebo in healthy subjects with mild hypertension on changes in Blood glucose concentrations and Insulin concentrations. At this point, the Sponsor was struggling to get a trusted research partner to design and conduct a clinical study. Both techniques of assessment and access to the relevant population were critical for the success of this project.

atlantiaclinicaltrials.com