The Effect of Melatonin Supplementation on Cancer-Related Fatigue during Chemotherapy Treatment of Breast Cancer Patients: A Double-Blind, Randomized Controlled Study.

Cancer-related fatigue (CRF) is a common distressing complaint of breast cancer (BC) patients treated with chemotherapy. Nutritional quality plays a pivotal role in CRF, while increased interest towards new pharmacological agents has been observed. Melatonin, an endogenous hormone that regulates the human sleep-wake cycle, could alleviate CRF. In the present randomized, placebo-controlled 3-month trial, we investigated the effects of melatonin intake (i.e., 1 mg/day) vs. placebo in BC patients on CRF. In both arms, the Mediterranean diet (MD) was implemented. Medical history, anthropometry and blood withdrawal were performed. CRF was evaluated by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire and MD adherence by the MedDietScore. In total, 49 BC women (median age 52 years) were recruited, namely N = 23 in the intervention arm and N = 26 in the placebo arm. At baseline, CRF was positively associated with body mass index (BMI), even when adjusted for age, waist circumference and blood indices related to disease prognosis (beta = -0.882, p = 0.003). At 3 months, both groups showed a BMI decrease (p < 0.05), but only the intervention group improved CRF compared to baseline (p = 0.003). No differences in CRF were observed between the groups. In conclusion, melatonin oral supplementation could ameliorate CRF in BC patients.

Mediterranean Diet and Physical Activity Nudges versus Usual Care in Women with Rheumatoid Arthritis: Results from the MADEIRA Randomized Controlled Trial.

In rheumatoid arthritis (RA), diet quality and nutritional status have been shown to impact the disease activity and adherence to the Mediterranean diet (MD) has been suggested as an anti-inflammatory regime to improve disease status and reduce cardiovascular risk. The Mediterranean DiEt In Rheumatoid Arthritis (MADEIRA) was a single-blind (statistician), two-arm randomized clinical trial, investigating the effects of a 12-week lifestyle intervention, including a personalized isocaloric MD plan with the promotion of physical activity (PA), supported through a clinical decision support systems (CDSS) platform, versus usual care in women with RA. Forty adult women with RA on remission were randomly allocated (1:1 ratio) to either the intervention or the control arm. The intervention group received personalized MD plans and lifestyle consultation on improving PA levels, whereas the controls were given generic dietary and PA advice, based on the National Dietary Guidelines. The primary outcome was that the difference in the MD adherence and secondary outcomes included change in disease activity (DAS28), anthropometric indices (BodPod), dietary intake, PA, vitamin D concentrations, and blood lipid profiles after 12 weeks from the initiation of the trial. At 3 months post-baseline, participants in the MD arm exhibited greater adherence to the MD compared with the controls (p < 0.001), lower DAS28 (p < 0.001), favorable improvements in dietary intake (p = 0.001), PA (p = 0.002), body weight and body composition (p < 0.001), blood glucose (p = 0.005), and serum 1,25(OH)2D concentrations (p < 0.001). The delivery of the MD and PA promotion through CDSS nudges in women with RA in an intensive manner improves the MD adherence and is associated with beneficial results regarding disease activity and cardiometabolic-related outcomes, compared with the usual care.

Lockdown Due to COVID-19 and Its Consequences on Diet, Physical Activity, Lifestyle, and Other Aspects of Daily Life Worldwide: A Narrative Review.

The novel coronavirus, termed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is responsible for the disease called coronavirus disease 2019 (COVID-19). Besides the important rates of mortality and morbidity directly attributed to the infection itself, many studies detected an important shift towards mostly unhealthy lifestyle patterns in previously healthy non-infected populations all around the world. Although most of the changes in lifestyle had or will have a negative impact on general population health status, some findings are encouraging. Notwithstanding that there was an obvious necessity for governments to apply national lockdowns, it is also necessary to identify and comprehend the consequences they have caused. A narrative literature review was performed, based on scientific articles and previous reviews. An accurate description of changes in eating habits and alcohol consumption, physical activity, mental health, daily routines, economic impacts, and broader effects on society is provided for each continent and different age groups through this review. The volume of selected scientific surveys encompasses approximately 400,000 persons.

Application of Clinical Decision Support System to Assist Breast Cancer Patients with Lifestyle Modifications during the COVID-19 Pandemic: A Randomised Controlled Trial.

Clinical decision support systems (CDSS) are data aggregation tools based on computer technology that assist clinicians to promote healthy weight management and prevention of cardiovascular diseases. We carried out a randomised controlled 3-month trial to implement lifestyle modifications in breast cancer (BC) patients by means of CDSS during the COVID-19 pandemic. In total, 55 BC women at stages I-IIIA were enrolled. They were randomly assigned either to Control group, receiving general lifestyle advice (n = 28) or the CDSS group (n = 27), to whom the CDSS provided personalised dietary plans based on the Mediterranean diet (MD) together with physical activity guidelines. Food data, anthropometry, blood markers and quality of life were evaluated. At 3 months, higher adherence to MD was recorded in the CDSS group, accompanied by lower body weight (kg) and body fat mass percentage compared to control (p < 0.001). In the CDSS arm, global health/quality of life was significantly improved at the trial endpoint (p < 0.05). Fasting blood glucose and lipid levels (i.e., cholesterol, LDL, triacylglycerols) of the CDSS arm remained unchanged (p > 0.05) but were elevated in the control arm at 3 months (p < 0.05). In conclusion, CDSS could be a promising tool to assist BC patients with lifestyle modifications during the COVID-19 pandemic.

Mediterranean Diet Implementation to Protect against Advanced Lung Cancer Index (ALI) Rise: Study Design and Preliminary Results of a Randomised Controlled Trial.

The Mediterranean diet (MD) has been inversely associated with lung cancer (LC) risk. Hereby we show the preliminary results of our prospective randomised controlled trial in inflammatory and nutritional status of LC patients after 3-month implementation of MD. In total, 30 patients with small-cell or non-small-cell LC (stages III-IV) were enrolled. They were randomly assigned either to Control group, receiving general nutritional guidelines, or the MD group, in which a personalised MD plan was provided. Medical and dietary history, anthropometrics, blood biomarkers, and circulating antioxidant vitamins were assessed. The main outcome was a significantly higher advanced lung cancer inflammation index (ALI) in patients of the control arm than those following MD (p = 0.003). In the MD group, platelets were significantly reduced at the study endpoint (p = 0.044). BMI and body fat mass remained unchanged in both arms, but serum glucose was significantly higher in control compared to MD group (p = 0.017). In conclusion, we showed for the first time that implementing a personalised MD for 3 months is promising to regulate prognostic biomarkers in advanced LC. The final results of our on-going trial will shed a light on the inflammatory, antioxidant and nutritional status of LC patients following MD.

Administration of an Intravenous Fat Emulsion Enriched with Medium-Chain Triglyceride/ω-3 Fatty Acids is Beneficial Towards Anti-Inflammatory Related Fatty Acid Profile in Preterm Neonates: A Randomized, Double-Blind Clinical Trial.

Intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to inflammation and lipid peroxidation in preterm neonates. We aimed to investigate the effects of a medium-chain triglyceride (MCT)/ω-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE) on plasma fatty acid (FA) profile and serum interleukin-6 (IL-6) in preterm neonates. In this double-blind randomized study, 92 preterm neonates (gestational age < 32 weeks, birth weight < 1500 g) were assigned to receive either MCT/ω-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group). Levels of FAs were measured at baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography mass-spectrometry. Serum IL-6 was measured with sandwich ELISA in 59 neonates. Plasma FAs changed significantly over time; the MCT/ω-3 PUFA-IVFE group showed higher ω-3 PUFAs (p = 0.031), eicosapentaenoic acid (p = 0.000), and oleic acid (p = 0.003), and lower ω-6/ω-3 PUFAs ratio (p = 0.001) and ω-6 PUFAs (p = 0.023) compared to control group. Linoleic acid was higher in the soybean oil (SO)-based IVFE arm compared to the MCT/ω-3 PUFAs-IVFE arm (p = 0.006). Both fat emulsion types decreased IL-6 compared to baseline, but changes were insignificant between groups. Administration of MCT/ω-3 PUFA-enriched IVFE in preterm neonates is beneficial in changing the FA profile consistent with attenuated inflammatory response.

Serum antioxidant capacity, biochemical profile and body composition of breast cancer survivors in a randomized Mediterranean dietary intervention study.

PURPOSE: Increasing evidence suggests that Mediterranean Diet (MD) is correlated with reduced risk of breast cancer (BC) and cancer mortality, since it modifies patients' serum antioxidant capacity, body composition and biochemical parameters. The aim of the study was to investigate whether a dietary intervention based on MD has a beneficial effect on these factors. METHODS: In this intervention study, seventy female BC survivors were randomly assigned to (1) the intervention group (personalized dietary intervention based on MD) and (2) the control group (received the updated American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Prevention and ad libitum diet). Both groups were assessed twice [beginning, end of study (after 6 months)] regarding their anthropometric and biochemical parameters, serum vitamin C, vitamin A, a-tocopherol and CoQ10 levels, dietary intake and adherence to MD. An additional intermediate analysis was conducted on participants' body composition and biochemical profile. RESULTS: Concerning the intervention group, body weight, body fat mass, waist circumference, body mass index as well as HDL-cholesterol were significantly decreased (P < 0.2%). An increase was observed in the vitamin C levels in blood (P < 0.2%). In the control group, body weight, body fat mass and serum total cholesterol rose (P < 0.2%). At the end of the study the two groups were significantly different considering blood glucose, vitamin C, polyunsaturated fatty acids, vitamin A and a-tocopherol levels. CONCLUSIONS: This randomized dietary intervention based on MD managed to ameliorate serum antioxidant capacity, body composition, adherence to MD and glycemic profile of postmenopausal BC survivors.

Maternal diet and breastfeeding duration of infants after NICU hospitalization in Greece: a cohort study.

OBJECTIVES: To investigate the role of maternal diet, personal characteristics and willingness to breastfeed on breastfeeding duration of hospitalized neonates as well as to evaluate the mothers' dietetic intake based on the national recommendations. METHODS: A sample of 161 pregnant women from Athens, Greece was followed up during pregnancy, labor and the first 40 weeks of lactation. The participants attended breastfeeding classes and were interviewed regarding their nutritional habits, personal characteristics and breastfeeding intention. A multivariable logistic regression, adjusted for maternal age, smoking, weeks of gestation, body mass index, mode of delivery was conducted in order to estimate the adjusted odds ratios of breastfeeding for at least 6 months for consuming additional serves of fruit or vegetables from the recommended by the national guidelines. RESULTS: The adjusted odds ratios for breastfeeding at 6 months was 2.15 (p = 0.05) for women consumed ≥3.5 servings of fruits/day. Moreover, the participants reported low conformity with the national dietetic guidelines. CONCLUSIONS: Mothers who consumed the recommended by the NDG fruit servings/day breast-fed their hospitalized newborns for a longer period. Despite the fact that our participants were highly motivated and willing to breast-feed, we argue that this relationship is highly unlikely to be biological.

Parenteral MCT/ω-3 Polyunsaturated Fatty Acid-Enriched Intravenous Fat Emulsion Is Associated With Cytokine and Fatty Acid Profiles Consistent With Attenuated Inflammatory Response in Preterm Neonates: A Randomized, Double-Blind Clinical Trial.

BACKGROUND: Soybean oil-based intravenous fat emulsion (IVFE) administered to preterm neonates can induce oxidative stress and inflammatory response, which are associated with severe complications of prematurity. This study aimed to test the hypothesis that administration of medium-chain triglyceride (MCT)/ω-3 polyunsaturated fatty acid (PUFA)-enriched IVFE in preterm neonates is associated with a cytokine and fatty acid (FA) profile consistent with attenuated inflammatory response. PATIENTS/METHODS: In a double-blind randomized study, 60 preterm neonates (gestational age 26-32 weeks) were randomized to receive either MCT/ω-3 PUFA-enriched IVFE (intervention group) or soybean oil-based IVFE (control group). Serum biochemistry, tumor necrosis factor (TNF)-α, interleukin (IL)-6, IL-8, α-tocopherol, and FAs were assessed at baseline, on day of life 15, and day of life 30 or at the end of intervention. RESULTS: All cytokine levels changed significantly across the 3 time points, whereas the type of IVFE had a significant effect on final IL-6 and IL-8 levels, which were lower in the intervention group. The difference in final IL-6 and IL-8 levels remained significant after controlling for bronchopulmonary dysplasia and/or infection. α-Tocopherol and FA values changed significantly over time. MCT/ω-3 PUFA-enriched IVFE administration was associated with significantly higher α-tocopherol, eicosapentaenoic acid, docosahexaenoic acid, and ω-3 PUFAs and lower linolenic acid, total PUFA, and ω-6/ω-3 PUFA values compared with soybean oil-based IVFE. Both IVFEs were well tolerated. CONCLUSION: Compared with the soybean oil-based IVFE, the MCT/ω-3 PUFA-enriched IVFE is associated with a more favorable cytokine and FA profile consistent with attenuated inflammatory response in preterm neonates.

Cholestasis, bronchopulmonary dysplasia, and lipid profile in preterm infants receiving MCT/ω-3-PUFA-containing or soybean-based lipid emulsions.

BACKGROUND: This study aimed to compare the effect of 2 lipid emulsions (LEs), a medium-chain triglyceride (MCT)/ω-3-polyunsaturated fatty acid (PUFA)-containing LE and a soybean-based LE, on the incidence of neonatal cholestasis, bronchopulmonary dysplasia (BPD), and lipid profile of preterm infants. Patients and METHODS: In this prospective, observational study, 2 groups of preterm neonates, the very low birth weight (VLBW) (n = 129) and the low birth weight (LBW) groups (n = 153), which received parenteral LEs for at least 7 days, were included. Infants received either MCT/ω-3-PUFA-containing LE (SMOFlipid, subgroup I) or soybean-based LE (Intralipid, subgroup II) according to the attending neonatologist's preference and availability. Full biochemical assessment was performed on days of life 15, 30, and 45 and on discharge. RESULTS: Of the VLBW infants, 7.4% and 13.3% of infants in subgroups I and II, respectively, developed cholestasis (P = .39; odds ratio [OR], 0.52; 95% confidence interval [CI], 0.15-1.76). The duration of LE administration was independently associated with cholestasis (P < .001; OR, 0.925; 95% CI, 0.888-0.963). The maximum amounts of lipids administered ranged between 1.6 and 3.6 g/kg/d in both VLBW subgroups. The VLBW subgroup I had lower incidence of BPD, lower alkaline phosphatase and phosphate, higher high-density lipoprotein (HDL), and lower cholesterol-to-HDL ratio on discharge than the VLBW subgroup II. The type of LE was independently associated with BPD and alkaline phosphatase. In the LBW group, the type of LE was not associated with clinical and biochemical parameters. CONCLUSION: In VLBW infants, the MCT/ω-3-PUFA-containing LE administration is associated with decreased BPD and more favorable lipoprotein profile. Although a trend toward a lower incidence of cholestasis was observed, a preventive effect of MCT/ω-3-PUFA-containing LE on parenteral nutrition-associated cholestasis is not supported.

Evaluation of the antioxidant effect of a new functional food enriched with Sideritis euboea in healthy subjects.

Sideritis euboea is a Greek plant that is traditionally consumed as a beverage (mountain tea). From in vitro studies, its extract has shown antioxidant and estrogenic activities. In our study we used S. euboea as an enriching food factor in order to produce a new functional food, a jelly dessert, in order to explore its antioxidant effects if consumed on a daily basis by healthy subjects. In this placebo-controlled clinical trial, 63 subjects were recruited for a 1-month nutritional intervention. Twelve subjects were excluded. The remaining 51 subjects were randomly classified in the intervention group (daily consumption of the jelly containing 0.3 g of S. euboea extract) or the placebo group (daily consumption of the same jelly without the enrichment). Vitamins C, A, and E, glutathione, coenzyme Q10, total nitrites, nitrates, total nitrogen oxide, nitrites/nitrates ratio, and total antioxidant status were measured in blood samples before and after the intervention. After the intervention, free glutathione and coenzyme Q10 increased, and nitrites decreased significantly in both groups. The other antioxidant markers were not altered. No statistical significant differences were observed between the two groups. The daily consumption of the functional food, for 30 days, had no effects on the antioxidant status of healthy volunteers.

Data analysis of the benefits of an electronic registry of information in a neonatal intensive care unit in Greece.

OBJECTIVES: This study assesses the results of implementation of a software program that allows for input of admission/discharge summary data (including cost) in a neonatal intensive care unit (NICU) in Greece, based on the establishment of a baseline statistical database for infants treated in a NICU and the statistical analysis of epidemiological and resource utilization data thus collected. METHODS: A software tool was designed, developed, and implemented between April 2004 and March 2005 in the NICU of the LITO private maternity hospital in Athens, Greece, to allow for the first time for step-by-step collection and management of summary treatment data. Data collected over this period were subsequently analyzed using defined indicators as a basis to extract results related to treatment options, treatment duration, and relative resource utilization. RESULTS AND DISCUSSION: Data for 499 babies were entered in the tool and processed. Information on medical costs (e.g., mean total cost +/- SD of treatment was euro310.44 +/- 249.17 and euro6704.27 +/- 4079.53 for babies weighing more than 2500 g and 1000-1500 g respectively), incidence of complications or disease (e.g., 4.3 percent and 14.3 percent of study babies weighing 1,000 to 1,500 g suffered from cerebral bleeding [grade I] and bronchopulmonary dysplasia, respectively, while overall 6.0 percent had microbial infections), and medical statistics (e.g., perinatal mortality was 6.8 percent) was obtained in a quick and robust manner. CONCLUSIONS: The software tool allowed for collection and analysis of data traditionally maintained in paper medical records in the NICU with greater ease and accuracy. Data codification and analysis led to significant findings at the epidemiological, medical resource utilization, and respective hospital cost levels that allowed comparisons with literature findings for the first time in Greece. The tool thus contributed to a clearer understanding of treatment practices in the NICU and set the baseline for the assessment of the impact of future interventions at the policy or hospital level.

Computer assisted total parenteral nutrition for pre-term and sick term neonates.

INTRODUCTION: Over the past few years, the use of total parenteral nutrition (TPN) has been established for pre-term and sick term neonates. At 'IASO' Hospital, a series of protocols implemented through the use of a computer programme has been developed to assist in the time consuming task of prescribing and preparing TPN in neonates. The algorithms used for neonates of a different gestational age are based on the protocols created through screening of literature and personal experience. This is important because it heralds a uniformity of the prescription of TPN at IASO and other hospitals where these protocols have been implemented. OBJECTIVE: The objective is to determine the extent of error occurrence of the manual method as opposed to the new computerized procedure of TPN formulation, and to assess the immediate benefits stemming from the computer programme's use, in terms of personnel time reduction. Furthermore, the usefulness of the automated compounder in the computer driven process of TPN solution formulation was also assessed. SETTING: Gynaecology Hospital 'IASO'. METHOD: For a period of 6 months, sick and prematurely born babies were included in the study. Calculations regarding the composition of TPN solutions were conducted both by computer and manually. MAIN OUTCOME MEASURE: The time needed to complete the procedure and the results' accuracy were measured and compared. RESULTS: Implementation of the protocols into practice via this computer programme has been found to reduce the time spent by the physician and the pharmacist on TPN solution preparation, but the most important contribution is the virtual elimination (no errors in computerized calculation) of errors in the complex task of prescribing and formulating TPN solutions. For example, the average time taken to prepare the individual TPN solutions was 5.2 min while the computerized procedure took 15.4 min. CONCLUSION: Use of this system can optimize pharmacists' and physicians' work and help prevent prescription and preparation errors.