Novel Medical Food for Glucose Control with Structured Nutrition Therapy vs Individualized Dietary Plan for Overweight and Obese Patients with T2D: A Randomized Clinical Study showing Significant Changes in HbA1c and Weight Loss

The clinical results of a randomized controlled research study that showed a novel medical food for glucose control in combination with a dietary plan resulted in significant reduction in A1C levels and body weight in overweight and obese patients with Type 2 Diabetes compared to an individualized dietary plan alone. The study, conducted by the Joslin Diabetes Center, was presented yesterday at the American Diabetes Association’s 76th Scientific Sessions in New Orleans, Louisiana. “Effective management of A1C levels, while challenging, is critical to reducing the risk of diabetes-related complications,” said Osama Hamdy, MD, PhD, FACE, Medical Director of the Obesity Clinical Program and Director of the Inpatient Diabetes Program at the Joslin Diabetes Center. “These data are encouraging, as overweight adults with Type 2 diabetes now have a more effective approach to reducing A1C and body weight through a structured dietary plan that includes Ultra Glucose Control.”

The study compared the effect of three Medical Nutrition Therapy models on A1C and body weight in 108 overweight and obese adults with uncontrolled Type 2 diabetes randomized into 3 equal groups over a period of 16 weeks. Group A met with a registered dietitian (RD) to develop individualized eating plans; Group B met with an RD to receive a structured meal plan that includes menu books, keeping a food log, and using 1-3 servings of a novel medical food for glucose control per day as calorie replacements; and Group C followed a plan similar to Group B in addition to receiving weekly phone coaching by RD.

Results showed, when compared to baseline data, A1C did not change in Group A while significantly decreasing in Groups B (-0.63±0.18%, p<0.001) and C (-0.67±0.19%, p<0.001). Change in A1C was significantly different between groups (p=0.0006). Body weight non-significantly decreased in Group A, but significantly decreased in Group B (-3.49±0.73 kg, p<0.001) and Group C (-2.73±0.78 kg, p<0.001).

This study follows another recent study conducted by the Joslin Diabetes Center evaluating glucose and insulin response to oatmeal versus commercially available diabetes-specific formulas. The study’s findings demonstrated that the novel medical food for glucose control used in this study also delivered a sustained and significantly lower glucose response over 4 hours that was superior to other commercially available formulas.

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