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Prevention of the Type 2 Diabetes by using Functional Olive Oil Enriched in Oleanolic Acid: The Prediabole Study: A Randomised Controlled Trial

AuthorsCastellano, José María ; Santos-Lozano, J. M.; Rada, Mirella ; Lapetra, Jose; Guinda Garín, Mª Ángeles ; Jiménez-Rodríguez, María C.; Cayuela, José Antonio ; Ángel-Lugo, Antonio; Vilches-Arenas, A.; Gómez-Martín, Ana M.; Ortega-Calvo, Manuel
Issue DateOct-2019
Citation17th Euro Fed Lipid Congress And Expo (2019)
AbstractDiabetes, one of the most prevalent chronic diseases, represents a major public health problem worldwide. In 2017, there were 425 million diabetic people in 2017, and a significant increase in the prevalence is expected in the next years, estimating that the number of diabetics in the world will achieve 629 million in 2045. An essential topic of diabetes approach is prevention, especially in people at high risk. Oleanolic acid (OA), a natural component of olive (Olea europaea L.), has demonstrated antidiabetic action in vitro and in experimental animals. However, a similar action had not been proved in humans. The PREDIABOLE (PREvention of DIABetes with OLEanolic acid) Study is a randomised and controlled trial, entirely performed in primary care, designed to assess whether the regular intake of an OA-enriched olive oil is effective in the prevention of diabetes. Diabetes is preceded by a period of dysglycemia, known as prediabetes, in which plasma glucose is higher than normal but not meet the criteria for diabetes. Prediabetes is defined by impaired fasting glucose (IFG), and/or impaired glucose tolerance (IGT) and/or a glycated hemoglobin (HbA1C) in the range 5.7¿6.4% (39¿47 mmol/mol). Prediabetes is associated with obesity, dyslipidemia and hypertension. Compared to euglycemics, people with both IFG and IGT have 20-fold higher risk of developing type 2 diabetes at short time. Therefore, they are ideal target population to investigate new preventive strategies against diabetes. In PREDIABOLE, prediabetic individuals (IFG + IGT) of both sex (176 patients, 30-80 years old) were randomised to receive OA-enriched olive oil (equivalent-dose 30 mg OA/day) (intervention group; IG) or the same oil not enriched (control group; CG). The main outcome was the incidence of new onset type 2 diabetes in both groups. After a median 27.5 months of follow-up, 48 new diabetes cases occurred, 31 in the CG and 17 in the IG. Multivariate adjusted hazard ratio was 0.45 (95% CI, 0.24-0.83) for the IG when compared with the CG. Intervention-related adverse effects were not reported. In conclusion, the PREDIABOLE Study demonstrates that the intake of an OA-enriched olive oil results in a substantial risk reduction of developing type 2 diabetes in prediabetic patients. Furthermore, this dietary intervention is well accepted by the population and also safe and palatable, showing high potential to be long-term sustainable. The burst of diabetes prevalence demands urgent measures delaying or avoiding the appearance of the disease. In this scenario, the use of OA-enriched functional foods is an interesting strategy. Nevertheless, further research is needed to consolidate the evidence of PREDIABOLE and to extend the use of OA in the design of new foods and drugs. Clinical Trial Registration: Current Controlled Trials number ISRCTN03372660
DescriptionTrabajo presentado en el 17th Euro Fed Lipid Congress And Expo (Oils, fats, and lipids. Driving science and technology to new horizons), celebrado en Sevilla del 20 al 23 de octubre de 2019.
Appears in Collections:(IG) Comunicaciones congresos
(IBIS) Comunicaciones congresos
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