Combatting metabolic syndrome, “EFSA: world’s toughest guidelines”Published: 06-09-2016, | Member: Newtricious
Dutch company Newtricious is developing ingredients to combat a global epidemic: metabolic syndrome. “We expect high demand, provided the accompanying health claims are solid.”
Establishing a new generation of specialized nutrition, using clinically-proven food ingredients, has been Newtricious’ raison d’etre since its foundation in 2006. After the successful introduction, a few years ago, of MacuView®, a natural dairy beverage that improves vision in healthy adults with normal signs of aging in the eyes, the company has turned its lens onto metabolic syndrome. This chronic metabolic disorder, common in people with obesity, is characterized by elevated insulin and low HDL cholesterol levels, high blood pressure, and a high triglyceride level.
“The current obesity epidemic began in the US, but is now a serious issue in Europe too, and Asia isn’t far behind”, says Nelissen. “The increasing number of people suffering from metabolic syndrome have an elevated risk of developing chronic illnesses such as type 2 diabetes and cardiovascular disease. Society has a need and a responsibility to break this cycle and limit the consequences: reduced quality-of-life and high healthcare costs.”
In 2011, Newtricious initiated the NWT-03 project, investigating the benefits of egg-protein hydrolysates (di-tripeptides) on vascular health. After a series of animal studies – mandatory for applications approved by the European Food Safety Authority (EFSA) – and two explorative intervention studies among healthy volunteers, a third intervention study recently began.
In the study, volunteers will use the protein hydrolysate for a period of four weeks, in order to assess effects of the hydrolysate on arterial stiffness -through measuring pulse wave velocity, glucose and lipid metabolism and blood pressure. “The study differs from our earlier studies in that the design is extended with measurements at four weeks, which will hopefully show a longer-term effect on specific markers in addition to acute (2h) and short-term (two days) effects that have been found before”, says Nelissen. The study primarily explores the longer-term effect of the hydrolysate and key heart-health measures and will complete early 2017.
The project sees Newtricious collaborating with recognized academic partners in the Netherlands and Western Europe, including Maastricht University, UMC Groningen, Wageningen UR and University College Cork. The company is also working on a facultative basis with research institutes elsewhere in the world. “We need top-quality research, to ensure our products are safe and well-characterized – fundamental in gaining health-claim approval from EFSA.
“EFSA guidelines are some of the strictest in the world”, says Nelissen. “This implies that with EFSA approval, the process should go easily and quickly in other countries. Some might need a few extra safety studies, but this work is nothing compared to starting a new health-claim dossier from scratch.”
Nelissen believes the introduction of the EFSA health-claim regulation process in 2011 was an important milestone on the road to healthy, trustworthy food products. “Pre-2011 there were many products on the shelves carrying misleading claims.” He acknowledges that the current guidelines are strict and leave little room for consultation. “But it is better to be safe than sorry: make them strict at first and ease them at a later stage, rather than the other way around.”
According to Nelissen, future EFSA guidelines could be made more nutrition-specific. “Whereas pharmacology targets a specific molecule(s) in the body, nutrition has several targets, exerting more-subtle effects. The subtlety of such effects makes them more difficult to prove in a healthy population – a key EFSA requirement.”
Apart from greater flexibility in the regulations, new technological developments in the coming decade will make health-claim substantiation much easier for manufacturers. “Consider the promise of big data and large initiatives like the European consortium PhenFlex, in which models and methods have been developed to reveal the subtle effects of nutrition. We expect these approaches to dramatically increase our understanding of both nutrition benefits and consumer behavior.”
The latter is crucial, according to Nelissen, because in the end it is not just EFSA registration that counts, it is the consumer. “Everyone should be able to trust – and so benefit – from our products.”