Clinical Trial Results: Fatty15 Can Treat Nutritional C15:0 Deficiencies

A randomized, double-blinded and placebo controlled clinical trial, recently published in the Journal of Nutrition, has added further support that many of us have a nutritional C15:0 deficiency called Cellular Fragility Syndrome. More importantly? Fatty15 can help fix it.

So, let’s do a deep dive into the latest clinical trial, including 1) evidence of nutritional C15:0 deficiencies, 2) the ability to safely and effectively raise C15:0 levels with fatty15, and 3) clinically relevant impacts of fatty15 supplementation to reverse Cellular Fragility Syndrome, including improved liver and red blood cell health. 

Sounds important. But first, what are C15:0 and fatty15?

C15:0 (pronounced see-fifteen) is a sturdy odd-chain saturated fatty acid. While it is primarily present in trace levels in dairy fat, C15:0 can also be found in some types of fish, meat, and plants. C15:0 is the first essential fatty acid to be found in over 90 years.

As a pure, bioavailable, science-backed, vegan-friendly and award-winning C15:0 supplement, fatty15 actively repairs, restores and revitalizes our long-term health at the cellular level by:*

• Strengthening our cell membranes to armor our cells (and us) against age-related breakdown
• Repairing mitochondrial function, which keeps our body’s energy-producers going
• Naturally activating receptors (including PPARs and AMPK) that regulate our metabolism, immunity, mood, sleep and appetite
• Naturally inhibiting damaging pathways (including mTOR and JAK-STAT) as a means to support longevity

All in, fatty15 provides 36+ cellular benefits to support our long-term health, which is 3x more than even the purest, highest performing omega-3 (EPA). 

Can you tell me a little more about nutritional C15:0 deficiencies and Cellular Fragility Syndrome?

We can. When our bodies have low C15:0 levels, our cell membranes become fragile, resulting in accelerated aging and increased risks to our long-term red blood cell, metabolic, heart, and liver health. This condition is called Cellular Fragility Syndrome, it is the first nutritional deficiency discovered in 75 years, and it may be affecting as many as 1 in 3 people.

Studies support that our cells need to maintain C15:0 levels greater than 0.2% of total fatty acids (or > 5 µg/ml, or > 20 µM) to avoid Cellular Fragility Syndrome.

Got it. So, what was the clinical trial about?

An important hypothesis around Cellular Fragility Syndrome is that nutritional C15:0 deficiencies are contributing to the shocking rise of nonalcoholic fatty liver disease (NAFLD), now also referred to as metabolic dysfunction-associated steatotic liver disease (MASLD). NAFLD is a metabolic liver disease, affecting 1 in 3 people and 1 in 10 children globally, that is a leading cause of liver cancer, liver transplants, and heart-related deaths.

Dr. Jeffrey Schwimmer is a gastroenterologist and global leader in pediatric NAFLD at the University of California San Diego and Rady Children’s Hospital. A previously published study by Dr. Schwimmer, which included 237 children between 8 to 17 years old, showed that the higher the blood levels of C15:0, the less fat the kids had in their liver.

As a next step, Dr. Schwimmer led a randomized, double-blinded and placebo-controlled clinical trial among a study population of young adults who were between 18 and 24 years old, to evaluate the following:

• Baseline C15:0 blood levels in a population purposely avoiding whole dairy fat
• Efficacy of fatty15 supplementation in raising C15:0 blood levels
• Safety of fatty15 supplementation
• Physiological effects of fatty15 supplementation across a variety of clinical indices

At baseline, study participants had overweight or obesity, as well as elevated liver enzyme levels (ALT and AST), which is indicative of suboptimal liver function. A total of 20 study participants took fatty15 (200 mg per day) for 12 weeks. Ten controls were given a placebo rice flour supplement.

Now that you know that, let’s get to the good stuff. Namely, what were the six key results from this clinical trial? 

Key Finding #1: At baseline, 2 out of 3 study participants met the criteria of nutritional C15:0 deficiency.

Yikes. Based on the recent Metabolites paper offering definitions for nutritional C15:0 deficiency, 20 of the 30 clinical trial participants were C15:0 deficient (< 5 µg/ml C15:0) at the start of this latest clinical trial. While it is estimated that 1 in 3 people have nutritional C15:0 deficiencies, this was a biased population that was purposely avoiding whole dairy fat and had elevated liver enzymes. 

Key Finding #2: Fatty15 supplementation successfully raises C15:0 blood levels.

As demonstrated in previous pharmacokinetic studies, the latest clinical trial reconfirmed that every 100 mg of fatty15 taken per day results in an average C15:0 level increase of around 1 µg/ml. Specifically, this study showed that taking 200 mg of fatty15 daily for 3 months increased C15:0 levels by an average of 1.88 µg/ml. 

Key Finding #3: Fatty15 is safe.

There were no differences in reported side effects between the fatty15 supplemented and placebo control groups, including reports of headaches, rashes, or stomach upset. This means that fatty15 did not cause any observed side.

Key Finding #4: Physiological benefits of fatty15 are dependent on achieving C15:0 levels above the C15:0 deficiency threshold.

As would be expected of a nutritional deficiency syndrome, observed health benefits depended on achieving adequate C15:0 levels. Of the 20 study participants who were provided fatty15 supplementation, ten achieved C15:0 blood levels > 5 µg/ml within 12 weeks. The other ten participants still had C15:0 levels below > 5 µg/ml at 12 weeks (as did all of the placebo controls).

Due to these differences, assessment of physiological effects were compared among the following three groups:

• The “Threshold Group”, who were supplemented with fatty15 and achieved C15:0 levels > 5 µg/ml (aka, C15:0 nutritionally sufficient).
• The “Sub-threshold Group”, who were supplemented with fatty15 and did not achieve C15:0 levels > 5 µg/ml (aka, C15:0 nutritionally deficient).
• The “Control Group”, all of whom were supplemented with a rice flour placebo control and did not achieve C15:0 levels > 5 µg/ml (aka, C15:0 nutritionally deficient).

So, why didn’t all fatty15 supplemented people achieve C15:0 levels > 5 µg/ml? 

Well, there are a few explanations. 

First and foremost, adherence to the protocol. Not every participant took the full fatty15 dose every day for 12 weeks, and this impacted their C15:0 levels. In fact, Dr. Schwimmer’s study showed that the more total C15:0 supplementation a person took over the 12 week time period, the higher their C15:0 levels. Poor adherence to the daily fatty15 regimen explained about 80% of the difference between those who got up and over the nutritionally sufficient threshold.

Other potential contributing factors to lower C15:0 increases in some individuals may include differences in gut absorption, metabolism, or if they ate high-fat meals. Limited studies in mice have shown that high fat diets can actually decrease C15:0 levels due to competition against other more highly prevalent “bully” fats.

Importantly, people with very low C15:0 levels may need higher C15:0 doses and more time to achieve nutritionally sufficient (healthy) C15:0 levels.

Okay, let’s get to the benefits observed in the “Threshold Group”, those people who routinely took fatty15 supplementation daily for 3 months and increased their C15:0 levels to over > 5 µg/ml.

Key Finding #5: Fatty15 supplementation raises hemoglobin, indicative of stronger cells.*

The group who achieved sufficient C15:0 levels (> 5 µg/ml) with fatty15 supplementation raised their hemoglobin levels, on average, by 0.6 g/dL. This effect was not seen in the other two groups. Hemoglobin is a key measurement of red blood cell health, and low hemoglobin levels are used to detect anemia. 

Why is this observed effect of increased hemoglobin meaningful?  Well, it supports the underpinnings of what happens when we have a nutritional C15:0 deficiency, referred to as Cellular Fragility Syndrome. Here’s how:

• C15:0 is a sturdy and essential fatty acid that strengthens our cell membranes. Low C15:0 levels in our cell membranes result in fragile cells, including fragile red blood cells.
• Over time, increases in fragile red blood cells result in lower hemoglobin, which is also a marker of accelerated aging.
• Previous studies have shown that C15:0 supplementation strengthens red blood cells, which raises hemoglobin, lowers red blood cell distribution width (RDW), slows cellular aging, and stems the downstream effects of Cellular Fragility Syndrome, including protecting liver, metabolic, and heart health.

The recently published clinical trial shows that, even among young adults, fatty15 supplementation increases hemoglobin in support of its red blood cell strengthening effect. Future clinical trials with C15:0 should also include RDW, which is another measurement of aging rate and long-term health.

Key Finding #6: Fatty15 supplementation lowers liver enzymes, indicative of improved liver function and health.*

Perhaps most importantly, the group who achieved sufficient C15:0 levels (> 5 µg/ml) with fatty15 supplementation had lower liver enzymes (aka, ALT and AST). On average, this group at baseline had ALT levels of 72 ± 80 U/L and AST levels of 45 ± 44 U/L. After 12 weeks of supplementing with fatty15, this group on average significantly decreased their ALT levels by 29 U/L and AST levels by 6 U/L.  This effect was not seen in the other two groups. 

Why is this observed effect of lowered liver enzymes meaningful?  It supports not only that fixing C15:0 deficiencies can help repair liver function, but that early phases of Cellular Fragility Syndrome affects both red blood cell and liver health. Both of which are fixable with fatty15.

That’s impressive! Not to be a Debbie Downer, but why didn’t fatty15 supplementation improve other indices, such as cholesterol, glucose, insulin and inflammation (C reactive protein, CRP)?

Good question, since other studies have repeatedly shown that fatty15 can improve these indices in various models. Further, a different randomized and controlled clinical trial showed that daily supplementation with the pure C15:0 ingredient in fatty15 over 12 weeks demonstrated lower LDL cholesterol among adult women who had a high BMI. 

So, why weren’t these broader effects seen in the In the most recent clinical trial? The answer likely lies in the baselines. When looking at the baseline status of this study’s young participants, their average cholesterol, glucose, insulin and CRP levels were within normal reference ranges. The only values that were outside of a normal reference range? ALT and AST.

This means that fatty15 may not significantly lower cholesterol, glucose, insulin and CRP levels if one has normal baseline levels. Instead, it normalizes physiological indices toward healthy, baseline function. In this study, fatty15 helped study participants: 1) move from low to healthy C15:0 levels and 2) move from high to lower liver enzyme levels. 

This study used 200 mg/day of fatty15 for 12 weeks. Is 100 mg/day not enough?

For most people, an added 100 mg/day of fatty15 is enough to achieve “healthy zone” C15:0 levels (> 5 µg/ml, > 0.2% total fatty acids, or > 20 µM). 

Participants in this study were more likely to have lower C15:0 levels based on 1) active avoidance of whole fat dairy products, and 2) presence of components of Cellular Fragility Syndrome (aka elevated liver enzymes). As such, the study protocol used a higher daily dose of 200 mg/day.

We currently recommend 100 mg to 200 mg/day of fatty15. If you are not feeling or seeing benefits from these doses, you can test your C15:0 levels through your doctor or with an at-home test. This will help guide and personalize your fatty15 journey.

To learn more about fatty15 dosing and C15:0 testing, check out this blog.

The take-home message

In summary, this latest clinical trial showed that people who reliably take fatty15 supplementation daily for at least 12 weeks can successfully increase C15:0 levels to the “healthy zone” of > 5 µg/ml (> 0.2% total fatty acids, or > 20 µM), strengthen red blood cell health, and support liver health. 

Most importantly, this study helps to confirm that there are many people who have nutritional C15:0 deficiency and Cellular Fragility Syndrome, which can be fixable with fatty15.* Global movement to improve health, one amazing person at a time? It’s on.

Read The Study