Prevention of type 2 diabetes in prediabetic patients by using functional olive oil enriched in oleanolic acid: The prediabole study, a randomised controlled trial.
Diabetes Obes Metab. 2019 Jul 31. Epub 2019 Jul 31. PMID: 31364228
José M Santos-Lozano
AIMS/HYPOTHESIS: 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 has not been proved in humans. The PREDIABOLE (PREvention of DIABetes with OLEanolic acid) Study is a randomised and controlled trial, performed in primary care, designed to assess whether the regular intake of an OA-enriched olive oil is effective in the prevention of diabetes.
METHODS: Prediabetic individuals (IFG + IGT) of both sex (176 patients, 30-80 years old) were randomised to receive 55 mL/day of OA-enriched olive oil (equivalent-dose 30 mg OA/day) (intervention group; IG) or the same oil not enriched (control group; CG). Main outcome was the incidence of new onset type 2 diabetes in both groups.
RESULTS: Forty-eight 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.
CONCLUSION/PERSPECTIVES: The intake of OA-enriched olive oil reduces the risk of developing diabetes in prediabetic patients. The results of the PREDIABOLE trial promotes the use of OA in new functional foods and drugs for the prevention of diabetes in individuals at risk of developing it.
CLINICAL TRIAL REGISTRATION: Current Controlled Trials number ISRCTN03372660 This article is protected by copyright. All rights reserved.