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.

Behavioral intervention with diet including 4 servings per week of red meat, 3 servings per week of processed meat, and 1 servings per week of poultry, for a total amount of 900 g per week of meat.

Behavioral intervention including diet with 4 servings per week of red meat, 3 servings per week of processed meat, and 1 servings per week of poultry, for a total amount of 900 g per week of meat with a dietary supplement of 100 mg/day of alpha-tocopherol in the form of tablet

Behavioral intervention with diet excluding fresh and processed meat, poultry but including 3 servings per week of any type of fish, excluding shellfish

Nutrition Aspect of Cancer

Diet Modification

Cancer of Colon

Diet including 4 servings per week of red meat (1 serving = 150 g), 3 servings per week of processed meat (1 serving = 50 g), and 1 servings per week of poultry (1 serving = 150 g), for a total amount of 900 g per week of meat.

Meat-based diet

Dietary intervention like the MBD with supplementation of alpha-tocopherol at a dosage of 100 mg/die. Available evidence suggests that alpha-tocopherol may help prevent colon cancer by decreasing the formation of mutagens arising from the oxidation of faecal lipids, by decreasing oxidative stress in the epithelial cells of the colon and by molecular mechanisms that influence cell death, cell cycle and transcriptional events (Pierre 2013, Bastide 2016, Bastide 2017, Diallo 2016). It is important to note that 200 mg/day of tocopherol was administered to 20,000 women for 10 years without side effects (Lee et al.,2005).

Meat-based diet supplemented with alpha-tocopherol (MBD-T)

Diet excluding fresh and processed meat, poultry but including 3 servings per week of any type of fish, excluding shellfish (1 serving = 150 g), for a total amount of 450 g per week. Diet will contain other sources of proteins (e.g. eggs, dairy, legumes/beans). There is suggestive evidence that fish and vegetable consumption has protective effects against CRC (Vieira et al., 2017).

Pesco-vegetarian diet

Unit of Clinical Nutrition, University Hospital of Careggi

Meat-based Versus Pesco-vegetarian Diet and Colorectal Cancer

Faecal Microbiome as Determinant of the Effect of Diet on Colorectal-cancer Risk: Comparison of Meat Based Versus Pesco-vegetarian Diets (MeaTIc)

Decrease (<25%) of DNA damage by faecal water (genotoxicity), using comet assay in a cellular model

Changes of microbiome and the relative metabolomics profiles from baseline

Global and specific peroxidation of omega-3 and omega-6 of the faecal water change from baseline

Pro- and anti-inflammatory profile's change from baseline

Oxidative stress profile's change from baseline

Francesco Sofi

Associate Professor of Clinical Nutrition

Azienda Ospedaliero-Universitaria Careggi

Randomized parallel open dietary intervention study with 3 arms of intervention

In this trial blinding of participants and investigators will not be possible because of obvious differences between the intervention diets

Group case: modified ketogenic diet to reduce at least 20% saturated fat, up> 50% of the acid supply monounsaturated, increasing> 50% polyunsaturated fatty acid content and a lower ratio w6 / w3 at least 50% compared to classic diet used by the control group

Epilepsy

Cardiovascular Disease

Non-alcoholic Fatty Liver Disease

Quality of Life

ketogenic diet

Nagila Raquel Teixeira Damasceno

Impact of Ketogenic Diet on Lipoproteins in Refractory Epilepsy

Classic Ketogenic Diet and Modified: Evaluation of the Therapeutic Potential and Impact on the Oxidative Profile, Lipidomic, Inflammatory and Size of Lipoproteins in Children and Adolescents With Refractory Epilepsy

age, income, disease, parent´s education, use of drugs and supplements, type of seizures, questions about quality of life

phase angle mass by impedance bioeletrical

Food record applied during 3 days to each time

Concentration of B-hydroxybutirate in plasma. Determination with kit Ranbut (Randox Laboratories Limited, Reino Unido).

Concentration in plasma. Determination with kit NEFAS(Randox Laboratories Limited, Reino Unido)

Determination of antioxidant concentration in plasma by HPLC

Determination in plasma by mass spectrometry

Patricia Azevedo de Lima

Ph.D. Student

University of Sao Paulo

Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months

Fibrosis

Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months

pentoxifylline with tocopherol

pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day, oral during 6 months.
Hyperbaric Oxygen Therapy at 100% in 25 sessions of 90 minutes 5 days per week (5 weeks) at 2,4 Ata in Hyperbaric chamber, starting in 3 or 9 weeks after randomization and beginning of drug treatment.

pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy

Hospital Universitario de Canarias

Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen

The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)

tocopherol/nécrose

Dietary Intervention With High Phenolic EVOO in CLL

Meat-based Versus Pesco-vegetarian Diet and Colorectal Cancer

Impact of Ketogenic Diet on Lipoproteins in Refractory Epilepsy

Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen

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