CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
High phenolic EVOO intake +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04215367
NCT04215367N/ACompleted

Effect of Dietary Intervention With High-Oleocanthal and Oleacin Extra Virgin Olive Oil in Patients With Chronic Lymphocytic Leukemia a Pilot Study

University of Peloponnese·interventional·Posted Jan 2, 2020·Updated Jan 2, 2020

In Brief

A clinical study evaluating High phenolic EVOO intake and No High phenolic EVOO intake for Chronic Lymphocytic Leukemia (CLL). Completed, enrolled 21 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGreece

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 2, 2020
Enrollment StartDec 15, 2018
Primary CompletionJun 5, 2019
Study CompletionDec 5, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.5 years ago

Interventions

High phenolic EVOO intakedietary

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

No High phenolic EVOO intakedietary

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