Here at OmegaQuant we are fortunate to have a front-row seat to the inner workings of the omega-3 world, especially where research is concerned. To that end, we’ve compiled what we believe to be the most important moments for omega-3 testing in 2019, some that are research-focused and others that are more market-focused. Regardless, we believe these events will likely shape how the scientific community and the public think about omega-3s and omega-3 testing for years to come.
#1-REDUCE-IT & VITAL Studies – All Roads Lead to Dose
This year played host to several influential events in the omega-3 world, especially on the science front. REDUCE-IT and VITAL, the biggest omega-3 intervention studies ever conducted, continued to bear fruit. In fact, the former is what most recently led to the FDA’s decision to expand the label claim for Amarin’s omega-3 EPA drug, Vascepa, to reduce cardiovascular risk. Originally, it was only approved to lower very high triglycerides, so this is a monumental move for a heart drug.
As for other notable studies, let’s start with a paper published in late October in Nutrients. In this study, researchers set out to determine if high-dose omega-3 is anti-atherosclerotic. To do this, they conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) of high-dose omega-3 on atherosclerosis.
The review looked at studies such as REDUCE-IT, which used high dose omega-3 (>3 grams/day) in Western populations OR moderate dose (1.8 grams/day) in Japan. The rationale for settling on the different doses between the two groups was that it would lead to similar final Omega-3 Index levels.
The goal was to find out if in these settings people had less coronary (or carotid) artery disease. Six studies met the criteria, and when the results were pooled, high-dose omega-3 was significantly associated with slower progression of atherosclerosis vs. placebo.
In this vein, researchers concluded that slowing the disease process in the artery wall is likely one of the mechanisms by which EPA and DHA lower risk for coronary heart disease (CHD) events.
According to William S. Harris, PhD, who was an author on this paper, Dr. Sekikawa (the study’s lead author) has long been interested in the difference between US Whites and Japanese living in Japan when it comes to heart disease risk, especially with respect to omega-3 fatty acids. “Dr. Sekikawa is convinced – and now more than ever with REDUCE-IT published – that lower risk is all about achieving higher blood omega-3 levels; it’s about DOSE,” Dr. Harris said.
Other possible mechanisms include decreased risk for blood clots or decreased risk for arrhythmia (due to changes in cell membrane omega-3 levels or to slowed heart rate secondary to a shift in autonomic nervous system activity). All of these can of course work together with lower triglyceride levels and lower blood pressure to reduce risk for CHD.
Another study Dr. Harris co-authored was published on October 15th in the Mayo Clinic Proceedings. This study evaluated the largest and most recent clinical trials on omega-3s and cardiovascular disease (CVD) (i.e., REDUCE-IT, VITAL and ASCEND).
The study also focused very much on dose.
“The results of REDUCE IT, in particular, suggest that optimal omega-3 benefits require a high-enough dose. It is an axiom in medicine that if the dose of any agent is too low, the agent will be ineffective. Why would the same not be true for omega-3 fatty acids?” the authors asked. “Hence, the goal in future omega-3 RCTs should be to achieve a target blood/tissue level of EPA and DHA (i.e., Omega-3 Index), regardless of what dose is required to accomplish this.”
#2-Publishing an Omega-3 Calculator for Researchers, Based on the Omega-3 Index
A study published in August in the American Journal of Clinical Nutrition (AJCN) established a new way to calculate how much omega-3 EPA and DHA will likely be needed to reach a high Omega-3 Index (8-12%).
Until now, there has been very little guidance about what dose of EPA and DHA should be tested in a study. And with the wide differences in study results in recent years, it is likely that dose played a central role in the relative success or failure of omega-3 studies. In other words, if the dose of EPA and DHA in a study wasn’t high enough to make an impact on blood levels (i.e. Omega-3 Index), there would most likely be no effect on the desired endpoint, leading to a neutral or negative result.
When it comes to cardiovascular disease (CVD) in particular, the literature supporting the benefits of omega-3s EPA and DHA has been mixed. On one hand, a 2018 meta-analysis concluded that current evidence does not support a role for omega-3s in CVD risk reduction.
On the other hand, three major randomized trials (ASCEND, VITAL and REDUCE-IT) reported in late 2018 showed that omega-3s significantly reduced risk for vascular death, myocardial infarction, and major adverse cardiovascular events. The latter study — REDUCE-IT — was particularly compelling because it used 4 grams of EPA (as opposed to the usual 0.84 grams of EPA and DHA) in statin-treated patients and found a 25% risk reduction in CVD events.
According to Kristina Harris Jackson, PhD, RD, who was an author on the AJCN paper, “A low dose could make a study show no effect of EPA and DHA, which makes the literature more indecisive and the consumer more confused,” she said. “Hopefully, ensuring the dose of EPA and DHA is high enough to reach a target Omega-3 Index level will clarify whether or not EPA and DHA are effective.”
#3-Establishing a Healthy Prenatal Omega-3 DHA Level for Women
The #1 reason DHA is important for pregnant women is because it has been identified in the medical literature as a risk factor for preterm birth. In late 2018, the Cochrane Review published a meta-analysis of 70 clinical trials involving nearly 20,000 women and found “strong evidence” that when women take omega-3s during their pregnancy, they can reduce their risk of preterm (before 37 weeks) and early preterm (before 34 weeks) birth by 11% and 42%, respectively.
Preterm birth (before 37 weeks) is now the second leading cause of death in children under five worldwide and accounts for half of all newborn deaths, according to a report by the March of Dimes and the World Health Organization (WHO). Early preterm birth (before 34 weeks) puts infants at even higher risk for death and a variety of adverse health problems, which can lead to extended time in the neonatal intensive care unit (NICU) and higher hospital costs.
Preterm births have increased in the last 20 years in almost all countries, and even though treatment for these infants has improved significantly, preventing preterm birth and carrying a fetus to term is still much safer, healthier, and cheaper.
While prematurity can negatively affect the health of both mom and baby, the financial toll is also significant. Figures from the March of Dimes show an uncomplicated birth costs around $4300. Each premature/low birthweight baby costs around $50,000 more. And when maternal costs are figured in, it is almost $60,000 more.
In a study published last December, OmegaQuant researcher Dr. Jackson estimated that over 70% of women of childbearing age in the US are not taking enough omega-3 DHA to achieve a healthy blood level. Following on the heels of that study, OmegaQuant launched The Prenatal DHA Test, which measures the amount of omega-3 DHA in the blood. Like the Omega-3 Index test, The Prenatal DHA Test requires a simple finger stick and one drop of blood. Achieving a score of 5% or higher is desirable, while anything below that number is associated with an increased risk of early preterm birth.
Establishing omega-3 DHA status during the different stages of pregnancy could play a crucial role in preventing prematurity. Until recently, omega-3 intake was confirmed primarily through dietary or supplemental records, but Dr. Jackson believes that measuring blood levels of DHA during pregnancy to guide this intake is needed.
INFOGRAPHIC: 5 Reasons Women Should Know Their Omega-3 DHA Level
There are very simple dietary changes you can make to increase your DHA level. First, you can (and should) eat two servings of low-mercury, high-DHA fish per week. Some options include salmon, tuna, anchovies, herring and mackerel.
It is important to remember that while dose matters, your DHA level matters most. Once you have established a dose that gets you to the 5% range or higher, then you need to maintain that dose or dietary regimen to keep your level in the optimal range.
Taking flaxseed oil supplements that are rich in the plant omega-3 fatty acid alpha linolenic acid, or ALA, will not affect your prenatal DHA level. If you are a vegan, vegetarian or allergic to or prefer not to eat fish and shellfish, algal DHA supplements are a great option.
#4-Globalizing Omega-3 Testing
In November, the International Society for the Study of Fatty Acids and Lipids (ISSFAL) issued a formalized statement around the importance of omega-3 EPA and DHA blood testing in research studies.
Statement No. 6, which relates to the importance of omega-3 blood testing in research studies was approved by the required (75%) majority of the ISSFAL Board and published in the December issue of Prostaglandins, Leukotrienes, and Essential Fatty Acids (PLEFA), the official journal of the society.
Summary of the statement:
Omega-3 long chain polyunsaturated fatty acid (n-3 LCPUFA) levels at baseline and post-intervention should be assessed and reported in future research to evaluate the efficacy of n-3 LCPUFA supplementation because — 1. there are numerous factors that affect n-3 LCPUFA levels in humans as described in the systematic literature review; 2. assessing intake of n-3 LCPUFA from the diet and/or supplements is not sufficient to accurately determine n-3 LCPUFA levels in humans; 3. some studies do not provide sufficient doses of n-3 LCPUFA to produce a significant impact on bloodstream/organ content and there is substantial variability in the uptake of n-3 LPCUFA into tissues between individuals.
The background to this statement is that it has been recognized for some time that many factors influence omega-3 status of individuals, according to Peter Clough, Honorary Secretary of ISSFAL. At the same time, studies featuring omega-3 supplementation have shown differing, sometimes conflicting results which may, at least in part, be due to variations in subjects’ fatty acid status.
With the support of ISSFAL’s position on omega-3 testing, OmegaQuant’s new lab partnership with Commonwealth Science and Industry Research Organization (CSIRO), which is Australia’s leading science agency, was particularly timely. Formed in November, this new collaboration with CSIRO will further support fatty acid research in Australia and Asia-Pacific and help expedite the processing of Omega-3 Index samples coming from this part of the world.
Earlier this year, OmegaQuant also inked an agreement with the University of Stirling in Scotland to process omega-3 blood samples coming from Europe.
Around the same time, OmegaQuant’s Omega-3 Index and Prenatal DHA test kits were registered in the EU as in vitro diagnostic medical devices. They are also CE-marked, which is the regulatory approval it needs to sell into Europe.
“We partnered with the University of Stirling to run our testing methods in their laboratory,” said Jason Polreis, CEO, OmegaQuant. “This way we are offering the same accurate, precise and scientifically validated methods at our three laboratories covering North America, Asia-Pacific and now Europe.”
These collaborations are important to OmegaQuant and the wider omega-3 community because it will help expedite the processing of fatty acid blood samples, further expanding the footprint of this test globally.
Omega-3 Testing Awards
As mentioned above, in February, OmegaQuant launched the first-ever Prenatal DHA Test for consumers and health practitioners to help guide the intake of the omega-3 DHA, which is an important nutrient women need before, during and after pregnancy. Alongside this effort, OmegaQuant created an educational initiative to bring more awareness and understanding to the importance of DHA for moms and babies, as well as the need to measure DHA levels to make sure they are getting enough. This educational effort is called the “Prenatal DHA Initiative.”
According to NutraIngredients-USA, the judges were impressed by the application of omega-3 testing to an especially sensitive population, to not only shine a light on the technology but also on the critical issue of DHA intake during pregnancy and how to increase those levels.
Stephen Daniells, PhD, Editor-in-Chief of NutraIngredients-USA, commented: “Omega-3 status during pregnancy is a hugely important issue that has significant implications for mother and child, and our judges were impressed by the technology and the potential public health benefits of this initiative. This was a very competitive category, with three very strong finalists, so congratulations to the OmegaQuant team on the Prenatal DHA Initiative.”
“Most American women don’t get enough DHA before or during pregnancy, so the Prenatal DHA Test can help personalize the issue and motivate women to get more DHA in their diet,” Dr. Jackson said “Our ultimate goal is to help make pregnancy safer for women and their babies, which is why we want to bring more awareness to the importance of getting more DHA in the diet and using a Prenatal DHA Test to guide appropriate intake.”
In August, OmegaQuant earned a spot on the 2019 Inc. 5000 list for the first time by growing 177% during the last three years. The 2019 Inc. 5000 companies achieved an astounding three-year average growth of 454%, and a median rate of 157%. The Inc. 5000’s aggregate revenue was $237.7 billion in 2018, accounting for more than 1.2 million jobs over the past three years.
“We are so proud of this accomplishment and hope to remain on this list for years to come,” said Jason Polreis, CEO, OmegaQuant. “We attribute our incredible growth to the quality work and service from our staff, the valuable test Dr. Harris invented, and the recent, growing interest personalized nutrition. Our nutritional status tests, such as the Omega-3 Index and Prenatal DHA Test, are just the beginning. We hope to expand our portfolio with similar nutritional status tests in the future.”
And then in September, OmegaQuant was a finalist for the Nutraingredients Asia awards in the category of Personalized Nutrition. This time the award entry featured the “Omega-3 Index Heart Initiative” to highlight the global public health need for omega-3s.
Given their connection to several aspects of health, particularly heart health, it is important to educate relevant audiences about these nutrients and encourage sufficient intake. At the same time, it crucial to make sure people have a way to measure, monitor, and modify their intake of omega-3s, so they can make sure their diets are delivering enough EPA and DHA. OmegaQuant’s goal with The Omega-3 Index Heart Initiative is to partner with like-minded organizations to help educate various audiences not only about the incredible value of omega-3s, but also the importance of knowing your omega-3 level (i.e., Omega-3 Index).
The simplicity of the Omega-3 Index test and the advice given to help people raise their omega-3 EPA and DHA level is very straightforward and easy to implement. Having a test that helps guide omega-3 intake and that has been substantiated by more than 100 clinical studies helps provide consumers the assurance that the test works for its intended use and that the results have significance for their health.
For 2020, it is our hope at OmegaQuant that the scientific community, health practitioners, and the public realize the importance of omega-3 blood testing, especially the Omega-3 Index since it has been validated in more than 100 studies. We look forward to what the New year will bring in the form of new science on omega-3s and further support for the relevance and application of the Omega-3 Index and Prenatal DHA Test.