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.

The intervention group received a guidance regarding their diet and physical activity using the motivational interviewing strategy to improve adherence to healthy behaviors. Participants received a guide with a motivational interviewing approach, which served as the basis for the interview process. The objectives in the intervention group were to consume four vegetables and two fruits a day, seven days a week, increase fiber consumption to more than 30 g daily, reduce fat consumption to no more 20% of the total energy consumed, decrease the consumption of sugary drinks and increase protein intake. Another goal was to increase the number of steps to 4,000 additional steps to those who have already walked.

The comparison group received a guide on medical care and nutrition with a traditional educational approach. The indication was to read and learn about the health-related topics included in the booklet that was given to them. These participants were visited in the same way as the intervention group to answer questions and monitor participation throughout the intervention.

Body Weight Changes

Mammographic Density

Quality of Life

The motivational interviewing strengthens the motivation and commitment to achieve a specific change through the induction and exploration of the reasons for modifying behavior. All this within an atmosphere of acceptance and compassion. It is about extracting the possible solutions to the change that is faced from the individual and his environment and not from the professional. This strategy is achieved by looking for the patient to feel motivated, and to express their problem and thus create discrepancy so that they evaluate their actions and reflect on the changes they should make.

Motivational Interviewing

Traditional education refers to the normal care given to breast cancer survivors. That is, they receive recommendations about their physical activity and diet but without any motivational approach.

Traditional Education

Centro de Investigación en Alimentación y Desarrollo

Impact of Diet and Physical Activity Changes on Body Weight, Biomarkers and Quality of Life in Breast Cancer Survivors

Intervention Program to Promote Changes in Diet and Physical Activity and to Evaluate Its Impact on Body Weight, Biomarkers of Disease and Quality of Life in Breast Cancer Survivors

Change in the amount of dense tissue compared to the amount of fatty tissue in the breast on a mammogram reported in percentage

Change in score of the scale of the Quality of Life Patient/Cancer Survivor Version. questionnaire carried out by Ferrell et al., (2012). This questionnaire analyzes the dimensions of physical, emotional, social, and spiritual well-being through a Likert scale. The minimum score to be obtained is 42 and the maximum score is 210 points, where the higher the score, the better the quality of life and the lower the score, the worse the quality of life.

Change in score of the scale of the Pittsburgh Sleep Quality Index. This questionnaire uses a Likert-type scale and provides an overall score of the quality of sleep in a range of 0 to 21, where the highest score refers to greater difficulties in all areas of sleep and a lower score gives a better sleep quality

Absolute telomere length (kilobase pair) (kbp)

The amount of bone mineral in bone tissue in g/cm2

The Revised Vital Orientation Test (LOT-R) was used, which is made up of a total of 10 items with a Likert response with five response options (from 0 = "strongly disagree" to 4 = "strongly agree "). The higher the level of optimism, the higher the level of optimism.

The State-Trait Anxiety Inventory, STAI was used. This questionnaire has twenty items for each of the subscales that are state anxiety and trait anxiety, with an alternative Likert response scale (from 0 = "nothing" to 3 = "a lot" for state anxiety and for trait anxiety of 0 = "Almost never" to 3 = "almost always"). Totals range from 0 to 60 for each subscale, a higher score reflects higher levels of anxiety.

Actually there is no plan to share IPD to other researchers

Graciela Caire Juvera, PhD

Centro de Investigación en Alimentación y Desarrollo A.C.

National Council of Science and Technology, Mexico

The intervention group received the motivational interviewing and the comparison group an orientation with a traditional educational approach. Both groups were followed for 8 months and the changes in the variables of interest were analyzed.

The intervention consists in feeding the subjects egg, one a day for breakfast during 5 weeks. At the end of the intervention, blood will be obtained to measure plasma lipids, glucose, insulin and inflammatory markers. All measurements will be finished 24 weeks after the intervention is finished. All data will be reported 1 year after completion of the study.

In this arm, subjects will consume oatmeal for a period of 5 weeks. Blood samples will be taken and different parameters will be measured including plasma lipids, glucose, insulin and inflammatory markers. All these measurements will be finished 24 weeks after completion of the study. All data will be reported 1 year after completion of the study.

Diabetes Mellitus

Inflammation

One egg per day as breakfast for 5 weeks followed by a 3 week washout period and 5 additional weeks on oatmeal. This is a randomized crossover design. Half of subjects started with the eggs and the other half with oatmeal. Blood lipids, glucose and inflammatory measurements will be finished 24. weeks after completion of the study. Data will be reported 1 year after the completion of the study.

Egg, one a day, for breakfast

Subjects will be fed oatmeal for a period of 5 weeks. After 3 weeks they will be switched to the alternate diet. This is a randomized control trail in which plasma glucose, plasma lipids and inflammatory markers will be measured. All these measurements will be finished 24 weeks after completion of the study. Data will be reported after 1 year of the completion of the study.

Oatmeal, one cup a day

Centro de Investigacion y Desarrollo

Egg Effects on Atherogenic Dyslipidemias, Glucose Metabolism and Inflammation in Diabetic Subjects

Egg Effects on Atherogenic Dyslipidemia, Glucose Metabolism and Inflammation in Diabetic Subjects

Glycosylated hemoglobin had to be < 9% as one of the inclusion criteria. This parameter was assessed after 5 weeks that the subjects consumed the egg and after 5 weeks after the subjects were consuming the oatmeal.

This parameter was assessed to ensure that no significant changes in LDL cholesterol occurred by egg intake or oatmeal intake. LDL cholesterol was assessed after 5 weeks of consuming the eggs and 5 weeks of consuming the oatmeal.

This parameter was measured to determine whether egg intake favorably would affect inflammation in diabetic subjects. Tumor necrosis factor alpha was measured after 5 weeks of consuming the eggs and 5 weeks after consuming the oatmeal.

carotenoid/necrosis

Dietary Intervention With High Phenolic EVOO in CLL

Impact of Diet and Physical Activity Changes on Body Weight, Biomarkers and Quality of Life in Breast Cancer Survivors

Egg Effects on Atherogenic Dyslipidemias, Glucose Metabolism and Inflammation in Diabetic Subjects

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