Effect of Ellagic Ácid on the Components of Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

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INTRODUCTION: Ellagic acid (EA) is a polyphenol that has shown health benefits in multiple experimental studies; mainly as an antioxidant, but also in hepatic steatosis, endothelial damage, hypertension, diabetes mellitus, visceral fat accumulation, dyslipidemia, insulin resistance, atherosclerosis,...

INTRODUCTION: Ellagic acid (EA) is a polyphenol that has shown health benefits in multiple experimental studies; mainly as an antioxidant, but also in hepatic steatosis, endothelial damage, hypertension, diabetes mellitus, visceral fat accumulation, dyslipidemia, insulin resistance, atherosclerosis, etc. There aren't studies that demonstrate the effectiveness of EA on MS; and since it is consumed by patients without any prescription, it is important to evaluate the effect of the administration of EA on the components of metabolic syndrome, insulin sensitivity, and insulin secretion. The current design is a randomized double-blind, placebo-controlled, clinical trial. METHODS: Male and female volunteers between 31 to 60 years of age, with MS diagnosis of MS according to the criteria of the International Diabetes Federation will be included, whether they accept participating and signing the informed consent. Patients with one or more of the following criteria will be excluded: History of liver, kidney, heart, or thyroid disease; systolic blood pressure ?140 mmHg, diastolic blood pressure ?90 mmHg, fasting blood glucose: ?126 mg / dL, triglycerides ?400 mg / dL, LDL cholesterol > 190 mg / dL; pregnancy or lactation; consumption of medications or supplements which interact with EA or that have effects on any of the components of the MS. Patients included, may be withdrawn from the study if they meet any of the following conditions: Withdrawal of the informed consent; compliance with some exclusion criteria during the study; treatment adherence <80%; intolerance to EC or placebo. OBJECTIVES: Main objectives are measuring and comparing before and after the intervention, the effect of EA or placebo on metabolic syndrome components, insulin sensitivity, and insulin secretion. HEADQUARTERS: The study will be carried out in the facilities of the Institute of Experimental and Clinical Therapeutics (INTEC), of the University Center of Health Sciences, in the University of Guadalajara. Guadalajara, Jalisco, Mexico.

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