The man behind the science and the brand is Dr. Mark Tarnopolsky, a physician and professor at McMaster University specialized in neuromuscular and neurometabolic disorders. He has spent his career investigating the therapeutic potential of exercise and nutritional supplements to address conditions ranging from nerve and muscle disorders to sarcopenia and obesity.
In 2014, he transmuted decades of research and clinical experience into nutra-pharmaceutical R&D company Exerkine Corp. and in 2020 launched consumer-facing supplement brand StayAbove Nutrition, which together continue to expand the science and the product portfolio.
As he explains, the goal is to help consumers stay above the disability threshold as they age and give athletes a competitive edge with synergistic formulations that sustain the mitochondria, the powerhouses of human cells.
NIU: How did your research lead you to enter the dietary supplement space and launch StayAbove Nutrition supplement brand?
MT: It was clear to me almost 30 years ago that the only therapies that helped our patients were properly designed exercise programs and targeted nutritional interventions. I was the first person to publish on the benefit of creatine in neuromuscular patients in 1999, and in 2001, I proposed that the best way to treat my patients was to use multi-ingredient supplements to target multiple final common pathways of cellular pathology including oxidative stress and mitochondrial dysfunction.
We showed that a multi-ingredient supplement lowered oxidative stress and improved mitochondrial function in genetic mitochondrial disease patients in 2007 and used this “mitocentric” approach as the core of most of our Exerkine/StayAbove Nutrition products to treat the two more common threats to most societies, aging and obesity.
The term “StayAbove” means to stay above the disability threshold as we age and to stay above the competition for athletes. I also coined the term “Exerkine” over a decade ago to describe the proteins that are released into circulation in response to exercise and have patented the use of IL-15 for skin and muscle health and we are evaluating other proprietary exerkine combinations.
NIU: What needs do Exerkine/StayAbove Nutrition seek to address in the market?
MT: With many decades of research into the benefits of exercise and nutrition, we are using a “nutra-pharmaceutical” approach for the development of novel, patented and highly effective and safe multi-ingredient supplements that target the pathological consequences of aging (sarcopenia, and reductions in bone, eye, cognitive and immune function), obesity (including fatty liver disease and infertility) and neuromuscular disorders (mainly mitochondrial disease, muscular dystrophy and lysosomal storage disease).
Our motto, “built and backed by science” reflects the ethos of basing our products upon solid pre-clinical models and clinical trials. It is clear that there is a lot of handwaving, half-truths and extrapolations in the nutraceutical industry, and we wanted to bring our research experience to the development of multi-ingredient supplements that complement exercise and a healthy lifestyle to promote optimized healthspan across the decades, from younger to older men and women.
NIU: What has gone into building the brand?
MT: We have built the company to date from angel investing through a friends-and-family raise and will be planning a Series A round later this year. Our development platform starts with a deep understanding of mitochondrial biology, muscle physiology, aging, obesity and neuromuscular disorders to conceptualize products and strategies that are centered around mitochondrial dysfunction as the core pathology target. We then assess concepts in pre-clinical studies to establish the mechanism(s) of action and safety and then test in phase 2 and 3 clinical trials.
NIU: What products are in the portfolio, and how were the ingredients selected in the formulations? What synergies?
MT: Our muscle enhancing product (Muscle5) and exercise recovery product (Recover9) were formulated from 30 years of R&D in the area and dozens of initial studies published in the area of creatine and protein metabolism and exercise recovery. Trim7 was based upon our mitocentric core, but we did multiple iterations to arrive at the essential seven ingredients that resulted in body fat loss through mitochondrial up-regulation in white adipose tissue (browning) without muscle loss. Our skin, fertility, radiation protection (see Cora Therapeutics), eye health and immunity products all use proprietary combinations of the mitocentric core and ingredients specifically chosen to target the specific final common pathways of pathology in each condition.
NIU: Could you share a bit about the body of research that backs the products? How many studies to date?
MT: We have published nearly a dozen peer reviewed papers in PubMed that back up our pre-clinical and clinical development. For example, we have three published phase 3 studies that show the efficacy of our Muscle5 product in younger and older adults, and there are two other publications related to inflammation and cognitive benefits from that study and one related to obesity coming soon.
Our Trim7 product has one PubMed paper that reflects multiple combinations studied to arrive at the patented final essential seven ingredients. An independent third party showed the dramatic benefits of Trim7 for metabolic associated fatty liver disease in a pre-clinical published paper. Finally, our phase 3 randomized trial was published in 2023 showing the loss of body fat with a preservation of muscle mass in obese men and women. An iteration of the Trim7 concept + creatine monohydrate and omega-3 showed dramatic benefits in obesity associated infertility and this product will be going into clinics this year.
We have multiple human clinical studies underway with a combination of Trim7 and Muscle5 in overweight and obese men and women starting an exercise program, a male infertility study, a metabolic dysfunction-associated fatty liver disease (MAFLD) study in men and women, and a study looking at the potential for Muscle5 to protect against obesity drug induced muscle loss and for Trim7 to enhance the benefits of obesity drugs after the plateau of effect after about a year. We have also published on the efficacy of our mitocentric approach in radiation protection and skin health and have studies underway in immune health and eye health.
NIU: What sets Exerkine/StayAbove Nutrition products apart in the market?
MT: We have a number of patented products, and all products are built and backed by our strong science and developed based upon a deep understanding of the pathophysiology of aging, obesity, neuromuscular disorders and the physiology of exercise and nutrition. Importantly, our R&D program identifies premium and standardized ingredients, which we then test for safety and efficacy. It is this rigorous development pipeline, in addition to our relentless pursuit of scientifically proven products, that yields the consumer a superior product that they can trust.
NIU: How are sales performing? How have the products been received by consumers to date? How has the brand grown since launch?
MT: We have focused on getting the pre-clinical and clinical studies completed/underway and filing patents and have only recently completed a “soft-launch” in Canada. Since launching at the end of 2020, we have consistently grown the brand by threefold each year.
Our main focus in 2024 is to start expanding into new markets through strategic partnerships with other brands or distribution companies. We have spent a lot of time working on palatability, taste and delivery strategies and most people who try our products love the taste (i.e., Muscle5 vanilla, Omega3) and convenience (Creatine1 tablets). Consumer feedback has been positive, and most customers become repeat buyers after experiencing the superior palatability, convenience and proven health benefits of our products.
NIU: What is next for Exerkine/Stay Above Nutrition?
MT: We are working on expanding our sales with strategic partnerships and independent growth. We have five clinical trials underway and starting this year (MAFLD, body composition enhancement, male infertility, GLP1-Ra potentiation with Trim7 and GLP1-RA attenuation of muscle loss with Muscle5. We have an ongoing pipeline of pre-clinical work in and will be launching our eye health (Occule8) and fertility kit (partnership with OTO-Coach) this year internationally. Our skin, immunity and an expanded sports nutrition line will be coming out in 2025.
NIU: What advice would you offer other startups in the industry?
MT: The customer base is becoming more educated and is demanding that products are truly “built and backed by science” and are not just based upon borrowing concepts and extrapolation. It is much more expensive and time consuming to build a company based upon solid science and real studies, but it is ultimately worth the long-haul vs a quick “pump and dump”.