NCT04215367

Dietary Intervention With High Phenolic EVOO in CLL

Completed NA Last updated 2 January 2020

What this trial tests

NA trial testing High phenolic EVOO intake in Chronic Lymphocytic Leukemia (CLL) in 21 participants. Completed in 5 December 2019.

Timeline

15 December 2018

Primary endpoint
5 June 2019

5 December 2019

Quick facts

Lead sponsor	University of Peloponnese
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	15 December 2018
Primary completion	5 June 2019
Estimated completion	5 December 2019
Sites	1 location across Greece

Drugs / interventions tested

• High phenolic EVOO intake
• No High phenolic EVOO intake

Conditions studied

• Chronic Lymphocytic Leukemia (CLL) — all drugs for Chronic Lymphocytic Leukemia (CLL) →

Sponsor

University of Peloponnese

Who can join

Adults 54 to 84, any sex, with Chronic Lymphocytic Leukemia (CLL). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Daily intake of extra virgin olive oil (EVOO), which is the major component of the Mediterranean diet and also a source of monounsaturated fat, may be partly responsible for the increased life expectancy of the Mediterranean people. A high dietary intake of EVOO is correlated with lower incidence of cancer, cardiovascular disease, metabolic diseases, Alzheimer's disease and osteoporosis Oleocanthal, a phenolic derivative of extra virgin olive oil, has important health promoting anti-cancerous properties, since it can inhibit the growth and promote the apoptosis of several cancer cells.

The purpose of the present study was to investigate the effect of dietary intake of olive oil rich in oleocanthal on hematological, metabolical, cell progression markers and disease progression in patients with Chronic Lymphocytic Leukemia. The aim is also to study the possible association of apoptosis in the mechanism of action of virgin olive oil phenols in a patient with CLL in order to find the possible mechanism of the cellular action of oleocanthal in neoplasia.

After the screening of \>300 EVOO samples the investigators selected an EVOO with high oleocanthal and oleacin concentration of 416 and 284 mg/Kg respectively (EVOO OC/OL). Pilot dietary intervention was made in a group of 21 patients with chronic lymphocytic leukemia (CLL) who did not follow any treatment. EVOO was administered 40 ml/day for six months. Biochemical, hematological and molecular markers were studied six month before the intervention and six month during the intervention

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Mediterranean Diet: An Update of the Clinical Trials.
   Finicelli M, Di Salle A, Galderisi U, Peluso G. · · 2022 · cited 105× · PMID 35889911 · DOI 10.3390/nu14142956
2. Potential Uses of Olive Oil Secoiridoids for the Prevention and Treatment of Cancer: A Narrative Review of Preclinical Studies.
   Emma MR, Augello G, Di Stefano V, Azzolina A, et al · · 2021 · cited 53× · PMID 33513799 · DOI 10.3390/ijms22031234
3. Polyphenols, the Healthy Brand of Olive Oil: Insights and Perspectives.
   Finicelli M, Squillaro T, Galderisi U, Peluso G. · · 2021 · cited 36× · PMID 34836087 · DOI 10.3390/nu13113831
4. The Effect of Dietary Intervention With High-Oleocanthal and Oleacein Olive Oil in Patients With Early-Stage Chronic Lymphocytic Leukemia: A Pilot Randomized Trial.
   Rojas Gil AP, Kodonis I, Ioannidis A, Nomikos T, et al · · 2021 · cited 23× · PMID 35127522 · DOI 10.3389/fonc.2021.810249
5. Oleocanthal as a Multifunctional Anti-Cancer Agent: Mechanistic Insights, Advanced Delivery Strategies, and Synergies for Precision Oncology.
   Jannati S, Patel A, Patnaik R, Banerjee Y. · · 2025 · cited 8× · PMID 40564985 · DOI 10.3390/ijms26125521
6. Selective Modulation of PAR-2-Driven Inflammatory Pathways by Oleocanthal: Attenuation of TNF-α and Calcium Dysregulation in Colorectal Cancer Models.
   Patnaik R, Varghese RL, Banerjee Y. · · 2025 · cited 7× · PMID 40243559 · DOI 10.3390/ijms26072934
7. Enhancing of cerebral Abeta clearance by modulation of ABC transporter expression: a review of experimental approaches.
   Loeffler DA. · · 2024 · cited 2× · PMID 38872626 · DOI 10.3389/fnagi.2024.1368200
8. Oleocanthal Induces Mitochondrial Dysfunction in Breast Cancer Cell Lines Depending on c-MET Expression.
   Quetglas-Llobera S, Morla-Barcelo PM, Roca P, Sastre-Serra J, et al · · 2026 · PMID 42072053 · DOI 10.3390/antiox15040410