The Effect of Dietary Intervention With High-Oleocanthal and Oleacein Olive Oil in Patients With Early-Stage Chronic Lymphocytic Leukemia: A Pilot Randomized Trial

Abstract

AimOleocanthal and oleacein (OC/OL) have important in vitro and in vivo antitumor properties; however, there is no data about their anticancer activity in humans. The aim of this pilot study was to test if patients at early stage of chronic lymphocytic leukemia (CLL) could adhere to and tolerate an intervention with high OC/OL extra virgin olive oil (EVOO) and if this intervention could lead to any changes in markers related to the disease.MethodsA pilot dietary intervention (DI) was made in patients with CLL in Rai stages 0–II who did not follow any treatment (NCT04215367). In the first intervention (DI1), 20 CLL patients were included in a blind randomized study and were separated into two groups. One group (A) of 10 patients consumed 40 ml/day of high OC/OL-EVOO (416 mg/Kg OC and 284 mg/kg OL) for 3 months. A second group (B) of 10 patients consumed 40 ml/day of low OC/OL (82 mg/kg OC and 33 mg/kg OL) for 3 months. After a washout period of 9–12 months, a second intervention (DI2) only with High OC/OL-EVOO for 6 months was performed with 22 randomly selected patients (16 from the DI1 (8 from each group) and 6 new). Hematological, biochemical, and apoptotic markers were analyzed in the serum of the patients. In addition, cellular proliferation and apoptosis markers were studied in isolated proteins from peripheral blood mononuclear cells.ResultsThe results of the DI1 showed beneficial effects on hematological and apoptotic markers only with High OC/OL-EVOO. During the DI2, a decrease in the white blood cell and lymphocyte count was observed (p ≤0.05), comparing 3 months before the intervention and 6 months after it. After 3 and 6 months of DI2, an increase (p ≤0.05) was observed in the apoptotic markers ccK18 and Apo1-Fas, and also in the cell cycle negative regulator p21, and also a decrease in the antiapoptotic protein Survivin, and in the cellular proliferation marker Cyclin D.ConclusionsThis is the first clinical trial with High OC/OL-EVOO that indicates that it could be a promising dietary feature for the improvement of CLL inducing the apoptosis of their cancer cells and improving the metabolism of the patients.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT04215367, identifier: NCT04215367.

The Mediterranean Diet: An Update of the Clinical Trials

“…Finally, Rojas Gil et al’s pilot study (NCT04215367) described the effects of the two main components of extra virgin olive oil (EVOO) on patients suffering from chronic lymphocytic leukemia (CLL) [ 106 ]. EVOO is a major component of the MedDiet, and it is accountable for the beneficial effect exerted by this dietary pattern [ 17 ].…”

“…Overall, these data posed the first evidence of the beneficial effect of high OC/OL EVOO on the improvement of CLL by exerting a proapoptotic influence on cancer cells. A multi-center larger trial must be carried out to confirm this preliminary evidence [ 106 ].…”

Rich Oleocanthal and Oleacein Extra Virgin Olive Oil and Inflammatory and Antioxidant Status in people with Obesity and Prediabetes. The APRIL Study: a Randomised, Controlled Crossover Study

“…Results suggested an acute anti-platelet effects in healthy men[12]. Another pilot study tested an intervention with high oleocanthal and oleacein EVOO in 26 patients at early stage of chronic lymphocytic leukemia[13]. Authors concluded that it could be a promising dietary approach for the improvement of this disease[13].…”

Mediterranean Diet as a Supportive Intervention in Cancer Patients: Current Evidence and Future Directions

“…In a small, prospective trial including 30 patients with advanced small cell lung cancer randomized to a personalized the MedDiet vs. a control diet, the MedDiet was associated with lower levels of inflammatory markers after 3 months, which suggests that it may positively influence cancer prognosis [ 14 ]. Another small, randomized trial concluded that a nutritional intervention based on extra-virgin olive oil rich in two polyphenols showing in vitro anti-proliferative properties, oleocanthal and oleacein, could slow the progression of chronic lymphatic leukemia [ 15 ].…”