Clinical Trial Shows Fatty15 Can Treat Nutritional C15:0 Deficiency Syndrome

Healthy Aging

Double Blinded & Placebo Controlled: Part I

Big science drop this week, folks. A second clinical trial that was published in The Journal of Nutrition and independently led by the University of California, San Diego, shows that fatty15 can treat nutritional C15:0 deficiencies and help reverse Cellular Fragility Syndrome.*

Over the next few weeks of Science Says!, we are diving into the most important findings from this study.

Why was this study done?

The lead investigator of this clinical trial was Dr. Jeffrey Schwimmer, who is a pediatric gastroenterologist at UC San Diego and Rady Children’s Hospital. Dr. Schwimmer is also the world’s leader in children’s fatty liver disease, which is a metabolic condition affecting 1 in 3 people globally, including 1 in 10 children.

Twelve years ago, Dr. Schwimmer reached out to our co-founder, Dr. Stephanie Venn-Watson, who published a paper on fatty liver disease in dolphins. They started comparing notes on what risk factors for fatty liver disease may be shared between dolphins and humans.

Three years later, Steph discovered a distinct condition in dolphins involving:

• Fatty liver disease
• Dysmetabolic iron overload syndrome (DIOS) with hyperferritinemia
• Insulin resistance
• Elevated cholesterol
• Chronic anemia

Further, Steph discovered that this condition was associated with low levels of odd-chain saturated fatty acids, including C15:0. Importantly, she also found that replenishing dolphins’ C15:0 levels resulted in improved metabolic and red blood cell health.

Several years later, Jeff published a paper in the Journal of Pediatric Gastroenterology and Nutrition showing that the higher the C15:0 levels in children, the healthier their livers. This led Jeff to initiate an independently-run clinical trial to assess the physiological effects of fatty15 supplementation on young adults who were susceptible to the same condition Steph was finding in dolphins.

As we recently shared, this condition is called Cellular Fragility Syndrome, which is caused by nutritional C15:0 deficiency. This is the first nutritional deficiency syndrome to be discovered in 75 years.

Key finding #1: Nutritional C15:0 deficiency is common.

This randomized, double-blinded, and placebo-controlled clinical trial included 30 participants who: 1) were 18 to 24 years old, 2) had a high body mass index (BMI), and 3) actively avoided whole dairy fat. At baseline, 2 out of 3 study participants had plasma C15:0 levels that met the criteria of nutritional C15:0 deficiency (less than 5 µg/ml).

Key finding #2: Fatty15 is safe.

Throughout this study, fatty15 caused no side effects.

Key finding #3: Fatty15 successfully raises C15:0 blood levels and treats nutritional C15:0 deficiency.

In this study, 20 participants took fatty15 (200 mg) daily for 12 weeks. The other 10 participants took a placebo (rice flour). While both groups had an average plasma C15:0 level of around 4.2 µg/ml at the beginning of the study, only the fatty15 group had significantly higher C15:0 levels at 12 weeks. On average, the fatty15 group achieved C15:0 levels of 5.5 µg/ml, which were up and over the nutritional C15:0 deficiency threshold of 5.0 µg/ml.

Key finding #4: Fatty15 dosing is scalable.

The results above are similar to other pure C15:0 pharmacokinetic studies. This means that fatty15 dosing is scalable. Let’s do some math for this one:

• Prior studies have shown that every 100 mg of fatty15 taken per day results in an average C15:0 level increase of around 1 µg/ml.
• Doing some math, that would mean taking 200 mg of fatty15 per day is expected to increase one’s C15:0 levels by around 2 µg/ml.
• This study showed that taking 200 mg of fatty15 daily for 12 weeks increased C15:0 levels by an average of 1.9 µg/ml.

This means that fatty15 can be used by most people at specific doses to achieve desired C15:0 levels.

Key finding #5: Not every person increased C15:0 equally. And reliably sticking to the fatty15 dosing routine counts.

The chart below from this clinical trial shows individuals’ changes in C15:0 levels over 12 weeks among those who took fatty15 (blue lines) and those who received the placebo (orange lines).

As you can see, there is variation among individuals regarding how much C15:0 increased while taking fatty15. In their paper, the authors explain that about 80% of this variation was explained by adherence (aka, did the study participant actually take 2 fatty15 capsules a day, every day, for 12 weeks?). The more reliably a person took fatty15 every day, the higher their C15:0 level.

Beyond adherence, however, there was still some variation among individuals. This is a good reason to test one’s C15:0 levels before and during their fatty15 journey. This can help guide personalized fatty15 dosing.

Well, that was a hefty dollop of information. To get you back to your Sunday, we’ll save how fatty15 improves Cellular Fragility Syndrome (including both improved liver function and red blood cell health) for the next couple of weeks. In the meantime, have a great week, everyone!