The Cleveland Clinic is beginning a series of clinical trials to assess the potential cardiovascular effects of Omega-7 fatty acids, a category of unsaturated fatty acids scientists are just beginning to understand.
According to Dr. Michael Roizen, MD, Chief Wellness Officer at the Cleveland Clinic, preliminary work suggests that Omega-7s confer heart-health benefits by increasing HDL cholesterol, and decreasing LDL and triglycerides.
"There is an ongoing debate, in which the beneficial role of Omega 7 is borne out by a fair amount of data, but all the studies have been done in irregular amounts and time periods," said Dr. Roizen, who gave a presentation entitled "Lessons Learned From The Cleveland Clinic and The Importance of the 'Odd Omega's' 3-7-9," at the recent Lifestyle Medicine Summit in Chicago.
One of the Cleveland Clinic studies will look at a product called Mega 10, recently launched by Metagenics. The product is so-named because it is a combination of Omega-7 and Omega-3 fatty acids, the latter of which are thought to have beneficial effects on the heart, eyes, and memory, according to Dr. Roizen. Another Cleveland Clinic study will look exclusively at Omega-7s without additional Omega-3 fatty acids.
Both studies will recruit 90 patients; the Omega-7 trial is expected to start in January or February, while the Mega 10 trial is expected to start in March or April, he added. "We hope to start outcomes studies within a year."
"These studies are looking purely at lipid changes and toxicological changes over two months," said Dr. Roizen, adding that the University of Puerto Rico just began another study of the Mega 10 combination product, and is recruiting 54 patients.
A New Option
"While Omega-3 has been available for a long time, Omega-7 wasn't, because nobody could get it pure at a reasonable cost; for example, it would cost $10 per pill to make it from macadamia nuts, and sources such as Sea Buckthorn are very hard to purify. But they recently found that after fish oil has been sold for biodiesel, if they purify it, it is high in Omega 7," he explained.
Omega-7, also known as palmitoleic acid, is technically not an "essential" fatty acid (EFA) because humans do produce small amounts of it (Omega-3s and other EFAs can only be obtained via foods). But production tends to decline with age and poor nutritional status. Dietary sources of palmitoleic acid include palm kernel oil and full-fat dairy products can provide small amounts, but they typically contain other less salutary components including palmitic acid and saturated fats.
A cross-sectional study involving 100 patients at high-risk for type 2 diabetes, showed a positive association between circulating levels of palmitoleic acid, insulin sensitivity and blood lipid metabolism (Stefan N, et al. Diab Care. 2010; 33: 405-407). Those with the highest baseline palmitoleic acid levels showed the highest insulin sensitivity.
The development of a new fish oil formulation is timely given the 2012 Oceana study, which examined more than 1,200 fish samples in 10 American cities. DNA testing found that 30% of the fish samples were mislabeled, that 94% of what was labeled at tuna was not tuna, and that some samples of red snapper contained tilefish, which has been banned in the U.S. due to mercury content. In short, adding fish to one's diet as a way of getting more Omega-3s is becoming less appealing, and for many people, less feasible.
Dr. Roizen noted that the "odd" omegas have multiple beneficial properties. For example, the 2010 Cardiovascular Health Study of 3,736 adults found that exogenous Omega-7 was associated with reduced body fat and lower inflammatory markers, in addition to the improved lipid profile. Increased Omega-7 intake also reduces C-reactive protein by 67%. All three of the "odd" omegas--3, 7 and 9--decrease inflammation and cardiovascular and cancer risks.
Omega 7 also lowers the risk of diabetes, he added. This was shown in a 2010 paper (pdf) by Dariush Mozaffarian, and colleagues in the Annals of Internal Medicine (Mozaffarian D, et al. Ann Intern Med. 2010;153: 790-799). The study, funded by the National Heart Lung & Blood Institute, showed that circulating trans-palmitoleate, the metabolite of ingested palmitoleic acid, is associated with lower insulin resistance, lower adiposity, reduced levels of atherogenic dyslipidemia, and lower incidence of diabetes.
Reversing Chronic Disease
During his presentation, Dr. Roizen also discussed the Wellness Program at the Cleveland Clinic, which has been able to turn around longstanding chronic disease trends in just seven years.
Founded on the core principles of functional medicine, the Cleveland Clinic program is based on the idea that food choices, inactivity, stress, and exposure to exogenous toxins are the main drivers of chronic disease---and therefore, the main keys to prevention. Dr. Roizen cited a 2007 study from the Centers for Disease Control indicating that these four factors account for 91% of all prescriptions written in the US.
With over 40,000 employees, the Cleveland Clinic is the second largest employer in the state of Ohio. Like all large companies, it was facing relentless increases in employee healthcare costs, the vast majority of which were connected with potentially preventable chronic diseases.
At the outset of the Cleveland Clinic project in 2002, cumulative incidence of these diseases was increasing by about 10% per year. This held true until 2005. By 2012, incidence of chronic disease among people involved in the Wellness Program was decreasing 2% per year.
The phenomenal turn-around is attributable to a number of key institution-wide changes that included making all Cleveland Clinic facilities entirely tobacco-free, elimination of sugared sodas, trans-fats and fast food chains from the Clinic's campus, and offering substantial insurance premium rebates to employees that participate in fitness programs, yoga classes, and stress reduction activities.
In short, the data prove clearly that it is possible to reverse chronic disease on a population basis, through comprehensive lifestyle-based interventions.
The right balance of Omega fatty acids is an important factor in the prevention equation--Dr. Roizen himself takes 900 mg per day of DHA, for the eye and brain, noting that the supplement has been associated with a six point difference in IQ, and a six-year younger memory score.
But equally important is the shift to a plant-focused diet.
He pointed to the Iowa Women's Health study, which showed that women consuming 11 servings per of day fruits and vegetables had a marked decrease in all-cause mortality, with a hazard ration of 0.67.
At the time the Cleveland Clinic Wellness Program was initiated, 80% staff and 90% of the institution's employees were deficient in this regard, he added.
When Dr. Roizen himself was pressed to name 11 different fruits and vegetables, he named 10 almost with hesitation: Brussels sprouts, cauliflower, broccoli, green beans, arugula, eggplant, carrots, tomatoes, avocado. Getting more of these into one's daily food routines is a good idea for anybody concerned with improving their health.