(P11-030-25) Efficacy of a Functional Food Supplement With Grape, Soy Protein, and Edamame as an Adjuvant Treatment in the Glycemic Control of Patients With Type 2 Diabetes Mellitus

Objectives: To prove the efficacy of a functional food supplement containing grape product, soy protein concentrate, organic edamame powder, and soy isoflavones in the glycemic control of patients with type 2 diabetes mellitus (T2DM).

Methods: This is an open-label observational study of 260 patients with the diagnosis and treatment of type 2 diabetes mellitus according to the latest Standards of Care in Diabetes available, including physical exercise, dietetic education and medical treatment, appropriately prescribed by a physician and a dietitian. All patients signed an informed consent form and were given 10 capsules a day of 500 mg of a proprietary blend of grape product, soy protein concentrate, edamame powder and soy isoflavones 90 days in addition to their standard treatments. Laboratory studies and medical checks were repeated at day 30, 60, and 90. Changes in disease treatment medications or treatment plan of patients terminated their participation in the study. Adverse events and side effects were recorded at each interval. Every patient was his or her own control.

Results: The medical observation was performed at five testing sites in Southern California, Northern California and Houston, Texas. Of a total of 260 patients recruited, with a median of 46 years, 38% female, 221 patients (85%) demonstrated a controlled glycemia of < 100 mg/dL at the end of the observation period, with a mean reduction of 17.5 mg/dL (p < 0.02) and a HbA1c of 5.7% or less, with a mean reduction of 0.7% (p < 0.02). No significant secondary effects were recorded.

Conclusions: The functional food supplement tested helped satisfactorily in the glycemic control of patients with T2DM.

Funding Sources: All diagnostic testing and doctor fees were funded by RAAS Nutritionals, LLC.