Clinical Trial Begins to Evaluate Physiological Effects of a Saturated Fat Found in Milk

SAN DIEGO, Sept. 23, 2021 (GLOBE NEWSWIRE) — A clinical trial to evaluate the physiological effects of a trace dietary saturated fat found in milk has recently started, led by Dr. Jeffrey Schwimmer at the University of California, San Diego. Dr. Schwimmer is a pediatric gastroenterologist at Rady Children’s Hospital specializing in fatty liver disease, an emerging metabolic disease now affecting one in four adults, and one in ten children, globally.

Mounting scientific evidence supports that pentadecanoic acid (also called C15:0) is the first essential fatty acid to be discovered in 90 years. It has been hypothesized that population-wide decreased intakes of foods, especially dairy fats, containing C15:0 may be causing nutritional C15:0 deficiencies that are driving the global rise in cardiometabolic and liver diseases, especially in younger people.

Over a dozen studies have shown that higher C15:0 levels in people’s diets and bodies are associated with a lower risk of having or developing diabetes, coronary heart disease, pancreatic cancer, obesity, metabolic syndrome, osteoarthritis, and fatty liver disease. One large prospective study involving 14,000 people followed over 14 years showed that people who had more odd-chain saturated fatty acids in their diet, including C15:0, had lower mortality.

This highly anticipated, 12-week, double-blinded, randomized and placebo-controlled clinical trial is assessing the ability for daily supplementation with FA15™, a pure powder, vegan-friendly and free fatty acid form of C15:0, to increase C15:0 blood levels, as well as the ability for FA15™ to positively affect physiological changes relevant to cardiometabolic, immune, and liver health. FA15™ recently gained Generally Recognized as Safe (GRAS) status as a food ingredient and is the only ingredient in fatty15, a healthy aging supplement launched earlier this year by Seraphina Therapeutics.

“After years of rigorous science and corroborating global studies, we are boldly bringing FA15™ and fatty15 to the world as a pure and vegan-friendly saturated fat that science strongly supports is good for our health,” said Dr. Stephanie Venn-Watson, Seraphina Therapeutics co-founder. “This clinical trial is a key next step toward demonstrating how FA15™ can replenish individuals’ critical C15:0 body levels and restore long-term health and wellness, especially as we age.”

Despite widespread belief that all dietary saturated fats are bad for our health, Dr. Venn-Watson discovered that C15:0, a trace odd-chain saturated fatty acid present in dairy fat, offered cellular health benefits, including improved cellular resilience, repaired mitochondrial function, and improved cellular signaling. These cellular benefits are of particular interest because they are relevant both to reversing the onset and progression of chronic cardiometabolic and liver diseases, as well as aging-related degradation.

Through a series of extensive studies conducted over three years, Dr. Venn-Watson also demonstrated that daily supplementation with pure free fatty acid C15:0 promoted healthy cholesterol and glucose levels, healthy body weight, and red blood cell and liver health in animal models of obesity, type 2 diabetes, and fatty liver disease. These findings were published in Scientific Reports, a Nature publication.

This past April, Dr. Schwimmer published a study including 237 children in the Journal of Pediatric Gastroenterology and Nutrition, that showed that higher levels of C15:0 in the blood were associated with lower amounts of fat in the liver. Fatty liver disease has become a common and serious problem affecting ten percent of children in the United States and has become the leading cause of liver cancer in children.

“Based upon our research, it is possible that a fatty acid supplement could make a difference in the lives of many young people. The first step is to affirm that supplementation is able to raise levels of C15:0 in the blood when compared to placebo. We will also look for signs that increasing blood levels of C15:0 leads to changes in physiology that have the potential to be of benefit,” said Dr. Schwimmer.

To learn more about C15:0, the associated studies and potential health benefits and use cases, please visit www.seraphinatherapeutics.com. To learn more about FA15™ and fatty15, please visit www.fatty15.com.

This clinical trial is registered at ClinicalTrials.gov (NCT04947176).

About Seraphina Therapeutics, Inc.
Seraphina Therapeutics, Inc. is a health and wellness company dedicated to advancing global health through the discovery of essential fatty acids and micronutrient therapeutics. Through rigorous breakthrough science, the company develops fatty acid supplements, food fortifiers and nutritional interventions to strengthen cells, keep mitochondria working and advance cellular homeostasis to counter age-related breakdown. With its team of industry-leading scientists, Seraphina Therapeutics challenges long held approaches to nutrition, enabling the creation of novel health products designed to support quality of life. The company is a spinout of Epitracker, Inc. and headquartered in San Diego. For more information, please visit www.seraphinatherapeutics.com and www.fatty15.com.

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