Dietary Intervention With High Phenolic EVOO in CLL

NCT04215367 | Completed

• 1 other identifier: 44917/13-12-2018
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

CLL; oleocanthal; Extra Virgin Olive Oil (EVOO); phenols; apoptosis

Outcome Measures

Primary Outcomes (2)

• Effect of the dietary intake of high phenolic EVOO on hematologic profile

  The effect of the dietary intake of high phenolic EVOO on hematologic profile was investigated comparing the complete blood count before (6 and 3 months) at the starting point of the dietary intervention and during (3 and 6 months) the dietary intervention in order to evaluate possible sustained hematologic improvement according to Rai et al criteria. Whole cell blood account was evaluated by hematological analyzer.

  1 year

• Effect of the dietary intake of high phenolic EVOO on apoptotic markers

  The effect of the dietary intake of high phenolic EVOO on apoptotic markers was investigated comparing the protein expression level on serum of the participants by ELISA. The apoptotic proteins Apo-1/Fas CD 95 (pg/ml) and CCK18 (U/L) and the antiapoptotic protein Survivin (pg/ml) were studied. The mentioned markers were evaluated at the starting point of the intervention, at 3 and 6 months during the dietary intervention with high phenolic EVOO in order to evaluate the in vivo the effect of high phenolic EVOO on protein expression of the studied apoptotic markers in CLL.

  6 month

Secondary Outcomes (4)

• Effect of the dietary intake of high phenolic EVOO on fasting glucose and correlation with the clinical outcome of the patients with CLL

  1 year

• Effect of the dietary intake of high phenolic EVOO on lipidemic profile and correlation with the clinical outcome of the patients with CLL

  1 year

• Effect of the dietary intake of high phenolic EVOO on liver function and correlation with the clinical outcome of the patients with CLL

  1 year

• Effect of the dietary intake of high phenolic EVOO on kidney function and correlation with the clinical outcome of the patients with CLL

  1 year

Study Arms (2)

High phenolic EVOO intake

EXPERIMENTAL

Patients with CLL consumed before their meals, 40 ml/day of EVOO rich in oleocanthal and oleacin for 6 months,

Dietary Supplement: High phenolic EVOO intake

No High phenolic EVOO intake

EXPERIMENTAL

Patient's history were recorded for third and sixth month before dietary the intervention, taking into consideration that the patients did'nt consume high phenolic EVOO.

Dietary Supplement: No High phenolic EVOO intake

Interventions

High phenolic EVOO intake DIETARY_SUPPLEMENT

During the pilot dietary intervention patients with CLL consumed before their meals, 40 ml/day high phenolic EVOO for 6 months

High phenolic EVOO intake

No High phenolic EVOO intake DIETARY_SUPPLEMENT

Medical record of each patient's was followed during 6 month before dietary the intervention

No High phenolic EVOO intake

Eligibility Criteria

• Age: 54 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed Chronic lymphocytic leukemia (CLL)
• Untreated CLL patients having Rai stage 0 to II
• Must be able to consume high phenolic EVOO according to the instructions

You may not qualify if:

• Neoplasic comorbidities and received any chemotherapy,
• Severe metabolic disease such us insulin dependent diabetes or severe kidney disease

Sponsors & Collaborators

• University of Peloponnese: lead
• National and Kapodistrian University of Athens: collaborator
• Harokopio University: collaborator

Study Sites (1)

University of Peloponnese, School of Health Sciences, Department of Nursing

Sparti, Lakonias, 23100, Greece

Location

Related Publications (16)

• Parkinson L, Keast R. Oleocanthal, a phenolic derived from virgin olive oil: a review of the beneficial effects on inflammatory disease. Int J Mol Sci. 2014 Jul 11;15(7):12323-34. doi: 10.3390/ijms150712323.

  PMID: 25019344 BACKGROUND

• Beauchamp GK, Keast RS, Morel D, Lin J, Pika J, Han Q, Lee CH, Smith AB, Breslin PA. Phytochemistry: ibuprofen-like activity in extra-virgin olive oil. Nature. 2005 Sep 1;437(7055):45-6. doi: 10.1038/437045a.

  PMID: 16136122 BACKGROUND

• Pang KL, Chin KY. The Biological Activities of Oleocanthal from a Molecular Perspective. Nutrients. 2018 May 6;10(5):570. doi: 10.3390/nu10050570.

  PMID: 29734791 BACKGROUND

• Sabattini E, Bacci F, Sagramoso C, Pileri SA. WHO classification of tumours of haematopoietic and lymphoid tissues in 2008: an overview. Pathologica. 2010 Jun;102(3):83-7. No abstract available.

  PMID: 21171509 BACKGROUND

• Hallek M. Chronic lymphocytic leukemia: 2015 Update on diagnosis, risk stratification, and treatment. Am J Hematol. 2015 May;90(5):446-60. doi: 10.1002/ajh.23979.

  PMID: 25908509 BACKGROUND

• Rai KR, Sawitsky A, Cronkite EP, Chanana AD, Levy RN, Pasternack BS. Clinical staging of chronic lymphocytic leukemia. Blood. 1975;46(2):219-234. Blood. 2016 Oct 27;128(17):2109. doi: 10.1182/blood-2016-08-737650. No abstract available.

  PMID: 27789434 BACKGROUND

• Domen J, Cheshier SH, Weissman IL. The role of apoptosis in the regulation of hematopoietic stem cells: Overexpression of Bcl-2 increases both their number and repopulation potential. J Exp Med. 2000 Jan 17;191(2):253-64. doi: 10.1084/jem.191.2.253.

  PMID: 10637270 BACKGROUND

• Marschitz I, Tinhofer I, Hittmair A, Egle A, Kos M, Greil R. Analysis of Bcl-2 protein expression in chronic lymphocytic leukemia. A comparison of three semiquantitation techniques. Am J Clin Pathol. 2000 Feb;113(2):219-29. doi: 10.1309/491W-L1TN-UFQX-T61B.

  PMID: 10664624 BACKGROUND

• Wójtowicz, Μ.; Wołowiec, D. Dysregulation of Apoptosis and Proliferation in CLL Cells, in Chronic Lymphocytic Leukemia ed. InTech Rijeka, Croatia. 2012, chapter 3, p37.

  BACKGROUND

• Gomes LC, Evangelista FCG, Sousa LP, Araujo SSDS, Carvalho MDG, Sabino AP. Prognosis biomarkers evaluation in chronic lymphocytic leukemia. Hematol Oncol Stem Cell Ther. 2017 Jun;10(2):57-62. doi: 10.1016/j.hemonc.2016.12.004. Epub 2017 Feb 1.

  PMID: 28183684 BACKGROUND

• Wójtowicz Μ, Wołowiec D (2012). Dysregulation of Apoptosis and Proliferation in CLL Cells, Chronic Lymphocytic Leukemia. www.intechopen.com.

  BACKGROUND

• Jaiswal PK, Goel A, Mittal RD. Survivin: A molecular biomarker in cancer. Indian J Med Res. 2015 Apr;141(4):389-97. doi: 10.4103/0971-5916.159250.

  PMID: 26112839 BACKGROUND

• Peter ME, Hadji A, Murmann AE, Brockway S, Putzbach W, Pattanayak A, Ceppi P. The role of CD95 and CD95 ligand in cancer. Cell Death Differ. 2015 May;22(5):885-6. doi: 10.1038/cdd.2015.25. No abstract available.

  PMID: 25849030 BACKGROUND

• Goren L, Zhang G, Kaushik S, Breslin PAS, Du YN, Foster DA. (-)-Oleocanthal and (-)-oleocanthal-rich olive oils induce lysosomal membrane permeabilization in cancer cells. PLoS One. 2019 Aug 14;14(8):e0216024. doi: 10.1371/journal.pone.0216024. eCollection 2019.

  PMID: 31412041 BACKGROUND

• Agrawal K, Melliou E, Li X, Pedersen TL, Wang SC, Magiatis P, Newman JW, Holt RR. Oleocanthal-rich extra virgin olive oil demonstrates acute anti-platelet effects in healthy men in a randomized trial. J Funct Foods. 2017 Sep;36:84-93. doi: 10.1016/j.jff.2017.06.046. Epub 2017 Jul 3.

  PMID: 29904393 BACKGROUND

• Rojas Gil AP, Kodonis I, Ioannidis A, Nomikos T, Dimopoulos I, Kosmidis G, Katsa ME, Melliou E, Magiatis P. The Effect of Dietary Intervention With High-Oleocanthal and Oleacein Olive Oil in Patients With Early-Stage Chronic Lymphocytic Leukemia: A Pilot Randomized Trial. Front Oncol. 2022 Jan 21;11:810249. doi: 10.3389/fonc.2021.810249. eCollection 2021.

  PMID: 35127522 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prokopios Magiatis, PhD

  National and Kapodistrian University of Athens

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Twenty one patients with Chronic lymphocytic leukemia (CLL) from the hematologic clinic of the General hospital of LaKonia (Greece), were enrolled to participate in the dietary intervention. CLL diagnosis was confirmed by standard criteria. Patients were untreated, in Rai stage 0 to II, did not met criteria to initiate chemotherapy and had no neoplasmatic comorbidity. Subjects were randomly selected from the Hematology Department of the General Hospital of Lakonia. Exclusion criteria were neoplastic comorbidities or severe metabolic diseases. Only one group participates in this study, which performed dietary intervention consuming EVOO rich in oleocanthal and oleacin. Clinical and molecular markers were registered 6 months before the intervention and 6 months during the intervention.

Study Record Dates

• First Submitted: December 7, 2019
• First Posted: January 2, 2020
• Study Start: December 15, 2018
• Primary Completion: June 5, 2019
• Study Completion: December 5, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)