It is widely reported that the adoption of EFSAs Article 13.1 health claim opinions will provide a ‘level playing field’ for marketing and advertising functional foods. In reality many companies will be placed at a significant disadvantage because their products contain additional nutrients that have not received a positive opinion from EFSA. Even though these products provide additional benefits to the consumer, manufacturers must meet the extra cost of these nutrients without obtaining a marketing advantage. In this situation performing ‘clinical style’ research trials could prove invaluable to demonstrate the extra benefits provided by the additional functional ingredients present. Rigorously conducted research trials with positive outcomes can provide unique and product specific Article 13.5 health claims. Such claims provide a significant marketing advantage both for raw ingredients and finished products, resulting in greater sales increases than similar products that lack these claims.

Many factors need to be considered, when planning a trial to ensure that positive findings can withstand scientific scrutiny from the EFSA review panel. These include the choice of subjects, the measures used to demonstrate effectiveness and the use of appropriate biomarkers. The selection of a research design that maximizes treatment effects and minimizes confounding factors is also essential to prevent unnecessary costs. Alimentarius have considerable expertise in conducting high quality human research trials, including UK government funded nutrition research for the Ministry of Agriculture Fisheries and Foods (MAFF) which is now DEFRA. Our scientific team have developed a range of research protocols to assess the efficacy of raw ingredients and functional foods in human subjects. The findings from these studies have been used to substantiate marketing claims relating to sports performance, physique development and weight management. For examples of our case studies relating to functional food research click here.

Alimentarius has close links with leading academic institutions and commercial laboratories in the UK, US and Europe. In addition to human trials we also have expertise in performing in vitro trials on raw ingredients and functional foods to substantiate marketing claims. Alimentarius recently co-ordinated a range of successful research trials on energy drinks, protein recovery drinks, ergogenic aids and weight management products. Our expertise in these areas is complimented by the battery of commercial biomarkers we offer. These meet the requirements of clinical standard food research and can be used to substantiate Article 13.5 health claims. The use of clinical biomarkers in food research is also becoming increasing important to help establish product safety and efficacy. Alimentarius can provide biomarkers specific to antioxidant capacity, vitamin status, mineral status, oxidative damage, lipid metabolism, renal function, liver damage, inflammation, muscle breakdown, red blood cell metabolism, immune function and omega 3, 6 and 9 fatty acids. Our team can also perform physiological measures including assessment of body composition, and a range of exercise metabolism and performance tests. Most importantly we have the necessary expertise to correctly interpret these biomarkers in humans, using a knowledge base that has been developed over more than 20 years experience in food research. The biomarkers can be assessed as part of a complete research package provided by Alimentarius, or as a ‘bolt on’ to research conducted elsewhere. For information on specific analyses and associated costs please contact us for a quote.