The clinical trial, which was sponsored by Metagenics and conducted at three universities, including the University of Connecticut-Storrs, the University of Florida, Jacksonville, and the University of California, Irvine, consisted of 89 women between the ages of 20 and 75. To be eligible for the study, the women had to have a LDL-C of more than 2.59 mmol/L (100 mg/dL), TG equal to or greater than 1.70 mmol/L (150 mg/dL), and meet two of the four remaining criteria for metabolic syndrome. The requirements were based on standards set forth in the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults—Adult Treatment Panel III (NCEP-ATPIII) criteria. Participants with heart, liver or kidney disease or who were using blood sugar or cholesterol-lowering agents were excluded. Those with type II diabetes were not excluded.
The women were divided into two groups and monitored for 12 weeks. One group participated in baseline exercise and consumed a low glycemic, Mediterranean style diet that included legumes, vegetables, lean protein, nuts and seeds, fruit, dairy, oils and whole grains. Though there were no caloric restrictions, researchers stipulated that test subjects eliminate trans fatty acids (partially hydrogenated vegetable oil), artificial sweeteners (sucralose, aspartame), high glycemic load fruits and vegetables (white potatoes, corn, bananas) and simple sugars (high fructose corn syrup, fruit juice, table sugar, evaporated cane juice, honey and maple syrup) from their diets.
The other group followed the same tenets but additionally consumed UltraMeal Plus 360°, a low glycemic index medical food formulated to deliver 15 grams of non GMO soy protein and two grams of plant sterols per serving. The medical food additionally includes “targeted phytonutrients for improving cellular signaling” in the form of reduced iso alpha acids from hops and Acacia nilotica bark extract, which have been clinically shown to improve fasting insulin and triglyceride levels. Each serving also contained an enhanced micronutrient profile to supply 35% or more of the RDI for most vitamins and minerals including 600 mg non-dairy calcium and 400 mcg folic acid (as folic acid and L-5-methyl tetrahydrofolate).
When compared with diet alone, the researchers observed nearly double the reductions in total cholesterol, LDL cholesterol, non-HDL-cholesterol, apolipoprotein B, ApoB/apoA-I, as well as better homocysteine levels and 40% greater net resolution of metabolic syndrome.
The results of the multicenter clinical trial were published in the May/June issue of the Journal of Clinical Lipidology, a publication of the National Lipid Association.
Taking a Bite out of Healthcare Costs
According to the Centers for Disease Control and Prevention (CDC) in the US, chronic illness affects nearly half of all adults and contributes to seven out of 10 deaths. Chronic illness also costs Americans more than $1.5 trillion annually in direct medical costs. It is for these reasons researchers and others in the medical profession believe that re-focusing medical practice treatments on the provision of lifestyle therapy will not only significantly improve the health status of most Americans, but will reduce costs.
“Preventing chronic illness is far more effective from both a cost and treatment perspective than treating the illness once it develops,” said Robert Lerman, MD, PhD, director of medicine and extramural clinical research for Metagenics Inc. “Physicians have evidence-based research that now enables them to actually use lifestyle therapy in their patients to help them avoid chronic illness by treating the cause, not just the symptoms of these conditions.”
As more countries adopt Western dietary habits and sedentary lifestyles, the number of chronic illnesses such as type II diabetes, obesity, heart disease, arthritis and autoimmune diseases has increased. “Chronic illness is draining our healthcare resources and keeping millions of people from enjoying healthy, vibrant lives. Many of these illnesses are the result of long-term lifestyle and behavior choices,” said Dr. Lerman.“This study is important because it shows how effective UltraMeal Plus 360°is in resolving metabolic syndrome and cardiovascular risk factors in affected individuals, and identifies a powerful new approach to combating chronic illness.”
Now that the aforementioned initial study has concluded, researchers are looking forward to conducing longer studies with larger populations, finding ways to disseminate their findings to healthcare practitioners, developing practice models to help doctors to implement lifestyle medicine, and advocating for insurance coverage.
“It’s very important for physicians to learn about these new findings. Doctors have not been trained to take a therapeutic lifestyle approach with patients who have metabolic syndrome,” said Mark McIntosh, MD, one of the principal researchers, director of Corporate Wellness and assistant professor in the Department of Emergency Medicine at the University of Florida, Jacksonville.
The researchers also believe this clinical trial underscores the importance of nutrigenomics, the science of how nutrition impacts genetic expression and its potential to improve health and avoid chronic illness. “Most physicians are accustomed to prescribing drugs for people with lifestyle-related conditions, even though the first line recommended course of treatment is lifestyle therapy,” said Wayne Dysinger, MD, current president of the American College of Lifestyle Medicine and chair of the Department of Preventive Medicine at Loma Linda University in Loma Linda, California. “This study reminds physicians that the option of prescribing food, in this case a medical food, should be considered. It demonstrates the ability of medical foods to reduce risk factors and improve health. The study results are a valuable addition to research on the impact of nutrition on health.”
In addition to Dr. McIntosh, the other two principal researchers were Maria Luz Fernandez, PhD, professor in the Department of Nutritional Sciences at the University of Connecticut, Storrs, and Wadie Najm, MD, clinical professor in the Department of Family Medicine at the University of California, Irvine.