Case Study

Assessing FMD in Overweight Adults

The efficacy of a product on flow mediated dilation (FMD) in healthy subjects with mild hypertension.

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Case Study Highlights

Study product

Functional Ingredient

Study population

healthy volunteers

Primary endpoint

Change in postprandial flow-mediated dilation

Study duration

week intervention period

Case Study Overview

Endothelial function (EF) plays an important role in cardiovascular health. Impaired EF is a prominent health concern, as it typically contributes to cardiovascular disease (CVD), i.e., hypertension, atherosclerosis, or myocardial infarction.

Designed and conducted at our Cork Facility in Ireland. The sponsor needed a trusted research partner to recruit 80 healthy overweight volunteers and assess the efficacy of their investigational product versus placebo on FMD.

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.

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