KEY INTERVIEW: New Research Allows Lipogen to Take Phosphatidylserine to New Heights

30 Mar 2016 --- The growing importance of phosphatidylserine (PS) as a leading component of every brain and nerve cell membrane in the body has been recognised in the past 20 years and, recently, as an important factor in neurodegenerative processes such as dementia. Lipogen, an Israeli company that has been involved in the production of PS for 25 years, has been producing PS from soy lecithin in a sustainable process for supplementation and food fortification.

“The amount of the PS molecule in our cell membranes diminishes after the age of 45,” Lipogen chief executive David Rutenberg, told NutritionInsight. “This lack of PS has been clinically shown to contribute to diminishing cognitive abilities. There is no good source of PS in our diet to get the optimal amount for brain cells and factors such as stress, illness, metabolic stress and ageing all contribute to the ability of the body to produce material declines.”

Lipogen commissioned clinical trials that sought to establish whether the supplementation of PS could lead to an improvement in cognitive abilities. PS was tested on animals and then humans and a clear statistical improvement was seen in cognitive ability after its ingestion. These initial findings led to approval to give PS US FDA Qualified Health Claim Status (QHC) and according to Rutenberg, it remains the only material ingredient that carries such a claim for cognitive function and dementia.

The development of vegetarian PS derived from soy lecithin became more pressing following the negative health issues surrounding bovine-derived ingredients in the 1980s. It was following various scandals that Lipogen was established and the first soy-derived PS was developed and marketed globally.

By the mid-90s, soy-derived PS was gaining momentum and following its QHC status in 2003, use of this vegetable-based PS was fully established.

“Even before the EU Novel Food act in 1997, soy-derived PS was being used as an ingredient in Europe so it didn’t need approval,” says Rutenberg. “But we got Novel Food status and today’s focus is to maintain the momentum for patents that relate to specific health claims, such as the combination of PS and phosphatidic acid (PA), which has been proven to be highly effective in the management of stress.”

“We have also carried out two major clinical trials that measure the reaction to social and psychological stress relating to the secretion of cortisol and how PS in combination can manage the effects of stress on an individual. Trials prove that efficacy is higher when PS is presented in combinations. This is our latest focus.”

Lipogen’s PSPA is a natural, high-quality blend of phosphatidylserine (PS) and phosphatidic acid (PA). It has been successfully demonstrated in two separate, controlled clinical trials to improve stress response under psychological and socially demanding conditions measured by lower levels of stress hormone (cortisol).

These recent findings have led to a new generation of supplements for cognitive functions, while at the same time Lipogen has developed a technique that will allow food companies to add specific phosphotidyl lipids to foodstuffs such as milk and creams that can also be added to cereals.

“Part of the challenge is to convey the message about the nutritional benefits to consumers in an easy way,” explains Rutenberg. “Many companies are reluctant to take a product to market that requires a lot of explanation. It is difficult to market such a specific ingredient. However, the new generation supplements will have clear function.”

All of Lipogen’s developments originate in their research centres, which aim to develop technology to make PS and other related ingredients available to the customer for a good and reasonable cost. A new research and development site is in the pipeline and should be completed by the summer. “Our new research centre will excel in that,” says Rutenberg. “We want to supply the industry with higher quantities of ingredients and are developing the center with new applications and technologies. So far, the results are very promising.”

“We need to ensure that the efficacy of materials gets better understood with time and the applications realise their importance. Considering the relationship with customers is also vital,” says Rutenberg.

Lipogen is in a good position in the market. Having established the production of commercial soy lecithin-derived PS and gaining patents, GRAS status and QHC, the company is in a position to realise market value and offer a service that customers can rely upon.

Next on the list of things to strive for is to be included on a new FDA program that regulates so-called botanical drugs. Rutenberg is confident that as a botanical ingredient that is important for certain neurological functions, PS is suitable for such a status. A certified drug status would elevate the product to a new level and allow it to be used in health programs in the US. This development could take several years, but it is something that Rutenberg is certainly on the path to achieve.

In the meantime, with new research being published all the time about the various neurological benefits of PS and PSPA, Lipogen has plenty to keep it busy and Rutenberg doesn’t see anything that will stop the company’s natural development.

By Kelly Worgan