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

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.

Chronic Lymphocytic Leukemia (CLL)

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

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

No High phenolic EVOO intake

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

Dietary Intervention With High Phenolic EVOO in CLL

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

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.

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.

The effect of the dietary intake of high phenolic EVOO on fasting glucose (mg/dL), was investigated comparing the fasting glucose before the intervention (6 and 3 months) at the starting point of the intervention, at 3 and 6 months during the dietary intervention with high phenolic EVOO. The correlation of the changes on the fasting glucose during the survey with the hematological outcome of the patient with CLL was also investigated.

The effect of the dietary intake of high phenolic EVOO on lipidemic profile (cholesterol (mg/dl), Low density lipoprotein (LDL- mg/dl), Hight density lipoprotein (HDL mg/dl), tryglicerides (mg/dl) was investigated comparing the lipidemic profile before the intervention (6 and 3 months) at the starting point of the intervention, at 3 and 6 months during the dietary intervention with high phenolic EVOO. The correlation of the changes on the lipidemic profile during the survey with the clinical outcome of the patient with CLL was also investigated.

The effect of the dietary intake of high phenolic EVOO on liver function was investigated comparing the biochemical markers of the liver function (Serum glutamic pyruvic transaminase (SGPT (U/L)), Serum glutamic oxaloacetic transaminase (SGOT(U/L) ), lactate dehydrogenase (LDH(U/L)), alkaline phosphatase (ALP(U/L)), gamma-glutamyl transferase (γ-GT(U/L) before the intervention (6 and 3 months) at the starting point of the intervention, at 3 and 6 months during the dietary intervention with high phenolic EVOO. The correlation of the changes on the liver function during the survey with the clinical outcome of the patient with CLL was also investigated.

The effect of the dietary intake of high phenolic EVOO on kidney function was investigated comparing the conventional biochemical markers of the kidney function Urea(mg/dl) and creatinine (mg/dl ) before the intervention (6 and 3 months) at the starting point of the intervention, at 3 and 6 months during the dietary intervention with high phenolic EVOO. The correlation of the changes on the kidney function during the survey with the clinical outcome of the patient with CLL was also investigated.

There is not a plan to make Individual participant data (IPD) available.

Andrea Paola Rojas Gil

Assistant Professor

University of Peloponnese

National and Kapodistrian University of Athens

Harokopio University

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.

Oral beclomethasone dipropionate at dose of 10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks plus MC- EVOO for 12 weeks at a dose of 2 tablespoons per day (1 before lunch and 1 before dinner). Each spoon will contain 10 grams of oil containing 5 mg of biophenols.

Oral beclomethasone dipropionate (10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks) plus placebo consisting of refined olive oil with low biophenols.

Ulcerative Colitis Chronic Mild

Beclomethasone dipropionate in addition to MC-EVOO

Beclomethasone dipropionate in addition to refined oil

IRCCS Casa Sollievo della Sofferenza

Monocultivar Coratina Extra Virgin Olive Oil in UC Patients

Supplementation of Extra Virgin Olive Oil Monocultivar Coratina in Patients With Active Ulcerative Colitis

Evaluation of the short-term clinical response rate in the 2 treatment groups

Evaluation of the clinical remission rate in the short term in the 2 treatment groups

Evaluation of the endoscopic remission rate after 3 months in the 2 treatment groups

Evaluation of the rate of patients with normalization of markers of inflammation in the short and medium term in the 2 treatment groups

Evaluation of the rate of adverse events in the 2 treatment groups

Angelo Andriulli

Medical Doctor

Casa Sollievo della Sofferenza IRCCS

Fondazione Schena

Patients will receive a bottle with experiental oil or placebo, consisting of commercial refined olive oil. No diffencences between the two bottles.

Control meal using standard breakfast foods.

This will consist of standard breakfast foods plus a berry smoothie.

This will consist of standard breakfast foods plus a sea buckthorn berry smoothie.

This will consist of standard breakfast foods plus a wild garlic dip.

Diet Induced Thermogenesis

Obesity Control

This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream

Control Meal

This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream plus a berry smoothie. The berry smoothie consists of blueberries, raspberries and blackberries.

Berry Treatment

This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream plus a sea buckthorn berry smoothie.

Sea Buckthorn Treatment

This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream. The wild garlic will be prepared and served as a dip alongside.

Wild Garlic Treatment

Rowett Institute of Nutrition and Health, Human Nutrition Unit

Thermic Effects of Some Scottish Plant Foods

The Thermic Effect of Some Plant Foods Native to Scotland: A Pilot Study.

Measured as the difference in Resting Metabolic Rate (RMR) during fasting and postprandial states

Based on the Respiratory Quotient (RQ) from RMR measurement and urinary urea, the proportion of carbohydrate, fat and protein used for energy production will be estimated.

Measured using 100mm continuous-line scales anchored at each end with opposing answers to satiety and palatability related questions

University of Aberdeen

Virgin olive oil obtained by traditional procedures (VOO);

Optimized virgin olive oil with a high phenolic content (OHPCO);

Functional olive oil (FOO) with both high phenolic compounds and triterpene content.

Cardiovascular Diseases

VOO was sequentially administered over 3 periods of 3 weeks preceded by 2-week washout periods in which participants were requested to avoid olives and olive oil consumption. During intervention periods, they were requested to ingest a raw daily dose of 30 mL of VOO distributed over 3 meals. Daily doses of VOO were blindly prepared in special containers, with the corresponding 30 mL VOO daily dose were delivered at the beginning of each intervention period to the participants. The participants were instructed to return the containers when collecting the next daily doses for the amount of unconsumed VOO to be registered. During washout periods participants were provided of sunflower oil for raw and cooking purposes.

Virgin Olive Oil (VOO)

OHPCO was sequentially administered over 3 periods of 3 weeks preceded by 2-week washout periods in which participants were requested to avoid olives and olive oil consumption. During intervention periods, they were requested to ingest a raw daily dose of 30 mL of OHPCO distributed over 3 meals. Daily doses of OHPCO were blindly prepared in special containers, with the corresponding 30 mL OHPCO daily dose were delivered at the beginning of each intervention period to the participants. The participants were instructed to return the containers when collecting the next daily doses for the amount of unconsumed OHPCO to be registered. During washout periods participants were provided of sunflower oil for raw and cooking purposes.

Optimized High Phenolic Content Oil (OHPCO)

FOO was sequentially administered over 3 periods of 3 weeks preceded by 2-week washout periods in which participants were requested to avoid olives and olive oil consumption. During intervention periods, they were requested to ingest a raw daily dose of 30 mL of FOO distributed over 3 meals. Daily doses of FOO were blindly prepared in special containers, with the corresponding 30 mL FOO daily dose were delivered at the beginning of each intervention period to the participants. The participants were instructed to return the containers when collecting the next daily doses for the amount of unconsumed FOO to be registered. During washout periods participants were provided of sunflower oil for raw and cooking purposes.

Functional Olive Oil (FOO)

University Hospital Virgen de las Nieves

New Industrial Procedures for Achieving a Nutritional Added Value of the Olive Oil. The NUTRAOLEUM Study

measured with a mercury sphygmomanometer after a minimum of 10 minutes rest in the seated position; the average of two measurements was taken for analysis.

a potential confounder variable concerning oxidative and anti-inflammatory status was recorded at the beginning and at the of the study, and assessed by the Minnesota Leisure Time Physical Activity Questionnaire validated for its use in Spanish men and women

determined in plasma by ELISA using two antibodies against antigenic determinants of oxidized apolipoprotein B molecule (ox-LDL, Uppsala, Sweden)

measured spectrophotometrically at 234 nm and 300 nm after Cu++ oxidation

measured as markers of compliance of the intervention, will be determined by gas chromatography-mass spectrometry

Endothelial function was measured at baseline (0h) and at 4 and 6h after each olive oil administration. Peripheral arterial tonometry signals were obtained using a device. Finger probes were placed on the middle finger of each subject's hand. These probes comprised a system of inflatable latex air cuffs connected by pneumatic tubes to an inflating device controlled through a computer algorithm. A constant counter pressure (pre-determined by baseline diastolic blood pressure) was applied. There was no occlusion of arterial blood flow. Pulsatile volume changes of the distal digit induced pressure alterations in the finger cuff, which were sensed by pressure transducers and transmitted to and recorded by the device. A decrease in the arterial blood volume in the distal finger tip caused a decrease in pulsatile arterial column changes, reflected as a decrease in the measured PAT signal.

oleuropein/cáncer

Dietary Intervention With High Phenolic EVOO in CLL

Monocultivar Coratina Extra Virgin Olive Oil in UC Patients

Thermic Effects of Some Scottish Plant Foods

New Industrial Procedures for Achieving a Nutritional Added Value of the Olive Oil. The NUTRAOLEUM Study

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