P054 REDUCTION OF BLOOD PRESSURE AND CARDIOVASCULAR RISK WITH IMPROVEMENT OF GLUCOSE AND LIPID METABOLISM BY A NUTRACEUTICAL BASED IN MULBERRY LEAF AND FENUGREEK IN SUBJECTS WITH PREDIABETES

Background and Objective: In Spain there are >5000000 prediabetic subjects, of which >500000 develop type 2 diabetes annually. Alpha-glucosidase inhibitors such as acarbose have been shown to prevent type 2 diabetes and reduce blood pressure, development of hypertension and cardiovascular risk. White mulberry (Morus alba) leaves contain 1-deoxynojirimycin, a powerful competitive alpha-glucosidase inhibitor. A nutraceutical containing Reducose (standardized white mulberry leaf extract), fenugreek (Trigonella foenum-graecum, an AMP-kinase activator), inuline (soluble fiber), Lactiplantibacillus plantarum (probiotic), niacin (vitamin B3), chromium and zinc (oligoelements) has been developed for use in patients with prediabetes. We endeavored to study its tolerability and efficacy on the metabolic profile, blood pressure and cardiovascular risk of the patients, with the change in the HOMA2-IR index of insulin resistance (as a proxy for the risk of developing type 2 diabetes) as the main outcome. Methods: In this ongoing open study, adult patients with prediabetes have been recruited to receive the mentioned nutraceutical daily for 6 months with an intermediate visit after 3 months. BMI, blood pressure, fasting glucose, insulin, lipid profile and HOMA2-IR were determined at each visit. Results: Of 94 recruited patients, 37 have completed the second visit. The HOMA-2 IR dropped by 21.5% (p=0.0016), the cardiovascular risk estimated by SCORE2 by 14.6% (p=0.0009), fasting glycemia by 7.6 mg/dL (p=0.0005), HbA1c by 0.22% (p<0.0001), non-HDL cholesterol by 12.4 mg/dL (p=0.0037), systolic blood pressure by 6.3 mmHg (p=0.0001), diastolic blood pressure by 5.2 mmHg (p=0.0236); the body weight and BMI did not change significantly, and there were no withdrawals due to adverse effects or serious tolerance issues. Conclusions: This nutraceutical was well tolerated and improved the metabolic (both glycemic and lipidic) profile, the blood pressure and the cardiovascular risk of patients with prediabetes. At present there are no licensed drugs for prediabetes in Spain, but this nutraceutical may be an option for these patients in combination with lifestyle changes.