The American Heart Association estimated that 50 million people in the U.S. have metabolic syndrome—a condition diagnosed in patients who present with a combination of risk factors such as high blood pressure, high blood sugar, abdominal obesity, low HDL cholesterol and high triglycerides. Although the Mayo Clinic asserted that while not all experts agree on the definition of metabolic syndrome or whether it even exists as a distinct medical condition, what’s certain is its ability to increases one’s risk for cardiovascular disease, diabetes and a host of other serious illnesses.

The first line of defense against the condition is a healthy diet and exercise. To that end, San Clemente, CA-based life sciences company, Metagenics, Inc. developed UltraMeal Plus and UltraMeal Plus 3600, a line of phytochemical-rich “medical food” powders that are to be mixed with water and consumed as a beverage.

According to Metagenics, each of the UltraMeal Plus incarnations are formulated to provide “specialized, multi-mechanistic nutritional support for patients with metabolic syndrome and cardiovascular disease by supplying a combination of acacia extract, reduced iso-alpha acids (RIAA), plant sterols and heart-healthy soy protein and isoflavones.”

“UltraMeal Plus and UltraMeal Plus 3600 have the same macronutrient profile,” explained Dr. Robert Lerman, MD, PhD, the company’s director of medicine and extramural clinical research. “UltraMeal Plus 3600 has additional plant sterols (2 grams per serving) and the proprietary Selective Kinase Response Modulators in the form of rho iso-alpha acids and acacia proanthocyanidins (150 mg and 30 mg, respectively).”

UltraMeal Plus 3600 has been the subject of ongoing research conducted by three major universities charged with determining if the product’s condition-specific nutrients could favorably address metabolic syndrome. Early results have been favorable.

In a press release, Metagenics stated that UltraMeal Plus 3600 formulation, which contains soy protein and phytosterols, has demonstrated cholesterol-lowering effects. “These components may help modify cardiovascular risk factors such as total- and LDL-cholesterol and apolipoprotein B which often coexist in patients with metabolic syndrome. Nutrients in its vitamin core are associated with prevention of elevation of another CVD risk factor, homocysteine. It also contains a proprietary blend of rho iso-alpha acids from hops and proanthocyanidins from the acacia plant. These phytochemical compounds have been shown to possess anti-inflammatory activity and demonstrated favorable modulations of the activity of protein kinases implicated in insulin signaling. Animal studies have documented reductions in both serum glucose and insulin.”

The two-arm, randomized trial involved 89 women from three study sites (University of Florida, Jacksonville, University of Connecticut, Storrs and University of California, Irvine). Each subject experienced 12 weeks of lifestyle therapy including a low glycemic load Mediterranean-style diet and regular, moderate exercise. Half of the women were randomly selected to consume two servings per day of UltraMeal Plus 3600—not as a meal replacement but in addition to regular meals. The beverage provided a total of 30 grams of soy protein, 4 grams of phytosterols, 300 mg rho iso-alpha acids, and 60 mg acacia proanthocyanidins.

Dr Lerman, one of the principle investigators of this clinical trial, said that while all subjects appear to show improvement in metabolic syndrome and risk factors for heart disease, those who additionally consumed UltraMeal Plus 3600 appeared to show even greater improvements, particularly in LDL-C, non-HDL-C, apolipoprotein B and Apo B/A-1 ratio.

“Even though there was no caloric restriction during the study, participants on average lost one pound per week over the 12 weeks,” stated Dr. Lerman. “We found that at the end of the study, 31.8% of the women in the control arm (consuming only the Mediterranean-style low-glycemic-load diet) had net resolution of metabolic syndrome. On the other hand, 44.4% of the women in the medical food arm (consuming the diet and UltraMeal Plus 3600) had net resolution of metabolic syndrome. In addition, there were statistically significant reductions in serum total cholesterol, LDL, non-HDL cholesterol, apolipoprotein B, apo B/apo A-1 and homocysteine levels in women in the medical food arm compared to those in the control arm.”

Dr. Lerman said the clinical trial has positive, far-reaching implications. “Lifestyle modification is recommended as the first line of treatment for metabolic syndrome. This study provides evidence that UltraMeal Plus 3600 medical food can enhance the effects of a lifestyle modification program not only for those with metabolic syndrome but also for those exposed to other cardiovascular risk factors,” he said. “Approximately one-third of the adult population in the United States is afflicted with metabolic syndrome, a risk factor for diabetes mellitus as well as cardiovascular disease, the number one killer in the US. Ameliorating and preventing the development of this metabolic disorder will have significant public health impact.

“The multi-center clinical trial results further support the use of Metagenics’ UltraMeal Plus 3600 medical food as part of lifestyle therapy addressing metabolic syndrome and other chronic illnesses that may stem from it,” he continued. “We believe these results are solid evidence that our unique combination of lifestyle and targeted nutrition offers a powerful approach for naturopathic physicians in managing their patients’ suffering from this all-too-common condition.”

Dr. Lerman said that the research team at the University of Connecticut is finalizing the research manuscript for submission to a peer reviewed journal. In the meantime, he noted that Metagenics is continuing its active research program focusing on ameliorating effects of chronic illness.

Metagenics formulas are not sold in health food stores and are only available through licensed healthcare practitioners.