The food and nutrition industry are constantly seeking for solutions that address the needs of cross- generational populations, like athletes, to active and ageing adults. Some common health concerns are exercise-induced inflammation and age-related loss of skeletal muscle mass, which are issues, no longer only relevant to professional athletes or adults in their senior years, but so many more consumers are looking to preventative supplementation in order to avoid future health issues. To gain validation, the next-generation ingredients are focusing on robust clinical trials and formulation.
Muscle protein synthesis is a process where the body naturally produces protein to repair muscle damage. However, ageing bodies process protein less efficiently which causes diminishing muscle strength and mass. Athletes also require more support when it comes to replenishing with nutrients to support wear and tear form exercise.
There have been numerous studies completed on Palmitoylethanolamide (PEA) - an endogenous fatty acid amide naturally produced in the body in response to pain, inflammation and stress/ PEA has a dual mechanism of action: to reduce inflammation/ pain and to activate muscle protein synthesis. It is proven to be beneficial amongst the ageing population and athletes, even those who encounter repetitive strain injury when it comes to joints and muscles.
PEA’s primary mechanism of action is its direct activation on PPAR-α, which initiates a cascade of events that causes the suppression of pain and inflammatory signals. PEA also acts on various other anti-inflammatory receptors (GPR55, TRPV1 etc.) and inhibits mast cell degranulation, thereby exerting anti-inflammatory, analgesic, and immuno-modulatory effects.
However, the levels of PEA in our body deplete with age and stress. Understandably, exogenous supplementation of PEA is required to replenish the body’s depleted stores, but it comes with challenges of poor absorption and limited format options. Gencor overcomes this by powering their branded PEA, Levagen®+, with LipiSperse® technology by Pharmako Biotechnologies, Australia.
Levagen®+ has a published pharmacokinetic study demonstrating it to be x1.75 times more bioavailable than the standard PEA. The cold-water dispersion technology allows the particles to freely disperse in aqueous environments, specifically within the stomach, thus increasing absorption. This allows brands to use a lower dosage in their formulation whilst maintaining the efficacy of this ingredient.
Joint and muscle health has evolved to include an ever-increasing array of applications, functions, and formats. We’re seeing many brands diversify their product offerings with innovative delivery forms like topicals, chocolates, functional beverages, and more. This feature of Levagen®+ also allows companies to explore various product formats, including effervescent tablets, capsules, shots, RTD mixes, powder, chocolates, and gummies.
When it comes to clinical evidence, Levagen®+ has numerous clinical studies backing its efficacy in the areas of inflammation, pain, and recovery with no adverse effects.
A double-blind, randomised, placebo-controlled study was performed on 28 healthy young male participants to evaluate the effects of orally dosed Levagen®+ on recovery after performing muscle-damaging exercise. Levagen®+ was consumed pre-exercise, post-exercise, 24 hours post-exercise and 48 hours post-exercise. The results indicate Levagen®+ supplementation helps with muscle recovery from repeat bouts of exercise performed within a short duration by decreasing muscle damage and promoting muscle protein synthesis. The results also reveal that supplementation of Levagen®+ allows exercise to be maintained at a higher intensity for a longer time.
As we move towards more transparency and easy accessibility of information, individuals have become more aware of the importance of educating themselves about the supplements/medicines that they ingest. They now seek for legal and safer alternatives to the traditional medicines. In the past, many people resort to CBD and NSAIDS (such as Ibuprofen) for pain medication. However, CBD comes with regulatory challenges and Ibuprofen, if taken excessively, can inhibit muscle protein synthesis amongst other side effects to the gut microbiome. In addition to this, there are insufficient high-quality evidence on the efficacy of CBD on healthy human population, restricting its users from making an informed decision on the use of this product.
Levagen®+ is often touted as “CBD alternative” as its mechanism of action targets similar pathways as CBD. PEA in-directly influences the endocannabinoid system by increasing levels of anandamide (AEA), an endocannabinoid also known as the 'bliss molecule', and thus has been shown to promote calming and pain-relieving properties.
Another study was completed to compare Levagen®+ with Ibuprofen on treating mild to severe headaches on 100 healthy adult participants. This study is currently under peer-review. Levagen®+ showed equivalence to Ibuprofen across the whole spectrum of headache resolutions and provided better results than Ibuprofen in time taken to resolve severe headaches i.e., Levagen®+ had a mean resolution time of 95.5 minutes whereas Ibuprofen had a mean resolution time of 116.9 minutes. Considering Ibuprofen is the gold standard pharmaceutical treatment for pain, these results are favorable as they prove Levagen®+ to be a safer alternative, whilst eliminating the possibility of having the common side effects associated with Ibuprofen.
Levagen®+ is a bioavailable PEA with clinical safety record, maintaining its position as a unique solution for healthy ageing and exercising individuals as it supports joint health and promotes regeneration of muscles. This allows individuals to stay mobile and pain-free, subsequently reducing their reliance on NSAIDS that come with negative side effects if used excessively.
Levagen®+ is produced with the highest quality of validations and manufacturing control and is GRAS, approved by Health Canada as an NHP, and accepted as a dietary supplement in U.S., Europe, Australia, and India. It is certified by LGC for 'Informed-Ingredient' where every batch is tested for absence of WADA-prohibited substances. As a reflection to Gencor’s continued commitment to quality, several more studies are being conducted on this ingredient to explore the possibilities of other end benefits Levagen®+ has to offer.
The muscle and joint health space is seeing significant commotion and innovation. Emerging ingredients like Gencor’s’ branded PEA, Levagen®+ are gaining momentum as clinical trials prove their efficacy, carving out a place in the market next to more established competitors. As this market continues to grow, products like Levagen®+ will gain further traction. As this space grows more competitive, success will depend on convincing consumers that your ingredient stands on a strong foundation of science, thus the future of PEA in this space is exceptionally bright, since so much clinical research already exists on its efficacy and effectiveness.
Millennials are now in their 30s, and this population is very focused on supply-side transparency and branded ingredients with clinical evidence, they are also very mindful of preventative supplementation and determined not to age as poorly as their parents. While Millennials represent a growing opportunity for future growth, most mobility, joint and muscle health consumers are still older adults or athletes looking for improvement in muscle health or recovery. Emerging ingredients like PEA are facilitating a new era of muscle health that appeals to a wider range of people who see movement as a fundamental part of their physical and mental well-being.