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DSM gains EU approval for enzyme that could relieve symptoms of gluten sensitivity

By Emma Jane Cash , 02-Aug-2017

iStock
iStock

The first enzyme aimed at the relief of symptoms of gluten intolerance has been granted novel food approval by EFSA and can now be used in the European Union, says DSM.

Tolerase G, launched by food and nutrition ingredients giants DSM, has been granted regulatory approval in Europe following its introduction into the US, Canadian, Australian and New Zealand markets.

The enzyme claims to effectively break down residual gluten - so reducing symptoms of gluten sensitivity in adults.

Aspergillus Niger prolyl oligopeptidase (AN-PEP), marketed by DSM under the name Tolerase G, is targeted towards consumers who adopt a gluten-free, or low-gluten diet, and need help breaking down residual gluten in the stomach.

Gluten-free boom

Gluten is the main structural forming protein found in wheat, barley and rye, and it is rich in an amino acid called proline. However, come people can have difficulty breaking down proline, causing some people to be sensitive to a gluten diet.

Market data from Mintel shows that the gluten-free trend has been growing extremely fast over  the last ten years, with millennials leading the market.

However, some experts have previously commented that gluten-free does not actually exist, since most products will contain small levels of gluten.

Instead, consumers can only hope to achieve a diet very low in gluten, but still risk consuming up to 300 mg per day of gluten.

This 'hidden’ gluten can often be found in products such as baked beans, chocolate, processed meats, soups and seasonings.

DSM say its new enzyme can help the human body to break down this unintentionally consumed gluten in the stomach.

“Gluten-free diets are becoming increasingly common, with many Europeans taking steps to reduce the adverse symptoms they experience after consuming such foods. However, it can be very difficult to avoid eating gluten altogether – especially when travelling or attending social events,” said Adrian Meyer, marketing manager of Human Health and Nutrition at DSM.

“Tolerase G offers manufacturers the opportunity to create unique food supplement products that significantly improve the lives of gluten sensitive consumers – giving this growing number of individuals the freedom to enjoying eating out, without the possible discomfort of residual gluten”.

It is the “first and only enzyme” that has shown effective results in a human clinical study and, according to DSM, has also proven to be more effective than current enzymes on the market which claim to break down gluten in the stomach.

‘Superior efficacy’

Tolerase G has been shown to degrade 86% of gluten in stomach during human clinical trials, by altering the gluten protein into small fragments.

In these smaller fragments, the stomach can digest the gluten protein more easily.

DSM’s trials have indicated that Tolerase G takes less than ten minutes to degrade the protein.

In one trial, 18 self-reported gluten sensitive individuals attended three test days where they were asked to eat porridge containing 0.5 g of gluten, as well as 160, 000 PPI of AN-PEP (high dose), 80, 000 PPI of AN-PEP (low dose) or a placebo.

Gastric and duodenal content was then sampled numerous times over a 180-minute period and was analysed for gluten epitopes.

It was found that participants taking either the high or low dose of AN-PEP had significantly lowered gluten concentrations in the stomach and the duodenum compared to those taking the placebo.

Researchers concluded “even in a physiological meal setting, AN-PEP significantly degraded most gluten before it entered the duodenum in self-reported gluten-sensitive subjects”.

However, the enzyme should not be used as a replacement for gluten-free diets, but is to be used alongside for best results.

The enzyme should also not be administered to children under the age of three.