Efficacy of Over-the-Counter (OTC) Medical Device Products as a Tool in Clinical Weight Management

Abstract

Background: Obesity is a significant public health challenge. Its prevalence is increasing at an alarming rate globally. Numerous slimming products crowd the market, with each offering a proprietary formulation with statements of alleged efficacy. Within the EU, one such class is Medical Device, featuring a range of marine- and vegetal-based fibers as the functional ingredient. Methods: An analysis was performed to investigate and compare the lipid binding performance of three medical devices consisting of: 1) a polyglucosamine; 2) a vegetal opuntia extract; and 3) a vegetal opuntia extract with vitamins using an industry-standard, validated test method. 0.5 gr of material from each product was studied. Results: The polyglucosamine exhibited a lipid binding capacity (691.7 g/g) more than 20 times the vegetal opuntia extracts. A significantly higher standard deviation (±12.1) was reported for the polyglucosamine medical device vs. the vegetal opuntia extracts (±1.3 - 4.8). However, the standard deviation reported for the former is approximately 1.7% of the mean value obtained from double determination, significantly smaller than that 2.5% - 15% observed for the extracts. Conclusions: Analysis of lipid binding indicated the polyglucosamine exhibited a substantially higher capacity than the vegetal opuntia samples. Further studies are needed to validate these in vitro results.