Impact of Caloric Restriction in Breast Cancer Patients Treated with Neoadjuvant Chemotherapy: A Prospective Case Control Study.

Background and aims: It is well established that caloric restriction (CR) may influence metabolic and hormonal factors involved in cancer development and progression. Recently, several studies have demonstrated that CR may have a favorable impact on the response to systemic therapy in breast cancer (BC) patients. However, there is a lack of data regarding the influence of CR during neoadjuvant chemotherapy (NACT). Our study's primary aim was to evaluate CR's impact on BC patients undergoing NACT. Secondly, we investigated the nutritional efficacy and safety of this intervention. Methods: We performed a prospective, case-control study in two breast units. A diet group consisting of 39 patients undergoing NACT and CR was enrolled in our study at the same time. CR consisted of a 30% reduction in caloric intake, which increased to 50% on the days before, during, and after the administration of chemotherapy. A control group of 60 patients that underwent the same treatment approach only followed the general dietary recommendations for BC according to WCRF guidelines. The diet group was monitored during the study for both dietary adequacy and weight trends. Results: CR combined with NACT showed a statistically significant therapeutic response in tumor size (OR 2.94, IC 1.07-8.01, p = 0.009) and lymph node status (OR 3.22, IC 1.22-8.56, p = 0.001) compared to NACT alone, even after the adjustment for all biological parameters. Our data also showed the efficacy and safety of this intervention in both anthropometric and biochemical analyses. Conclusions: Patients who adhered to CR showed a better response to NACT, both in the breast and in the axillary lymph nodes, compared to the patients in the control group. Furthermore, the CR diet combined with NACT showed good tolerance and safety.

The Effects of Time-Restricted Eating on Metabolism and Gut Microbiota: A Real-Life Study.

The metabolic benefits of time-restricted eating (TRE) in humans are statistically significant but not clinically relevant. Few data are available about the effects of TRE on the gut microbiota. We compared the effects of a TRE regimen (<12 h feeding; n = 25) with a time-unrestricted (TUE) regimen (>12 h feeding; n = 24), on the clinical and dietary variables and gut-microbiota composition in patients with obesity, who were subjected for 12 weeks to the same caloric restriction. Median weight loss was 4.0 kg and 2.2 kg in the TRE and TUE groups, respectively, with a between-group borderline difference (p = 0.049). No significant between-group difference was found in other dietary, anthropometric, or laboratory variables. There were no substantial between-group differences in alpha and beta diversity or gut-microbiota composition. The TRE group showed a significant increase in the frequency of Lachnospiraceae, Parasutterella, and Romboutsia at the study's end. A TRE regimen induced small changes both in metabolic/dietary variables and in the gut-microbiota composition, with respect to the TUE. The microbial changes we have found were of uncertain clinical significance.

Home parenteral nutrition versus artificial hydration in malnourished patients with cancer in palliative care: a prospective, cohort survival study.

OBJECTIVE: The evidence base for home parenteral nutrition (HPN) in patients with advanced cancer is lacking. To compare the survival of malnourished patients with cancer undergoing palliative care who received HPN with a homogeneous group of patients, equally eligible for HPN, who did not receive HPN. DESIGN: Prospective, cohort study; tertiary university hospital, home care, hospice. METHODS: Patients were assessed for HPN eligibility according to the guidelines. In the eligible population, who received both HPN and chemotherapy was excluded, while who received only HPN was included in the HPN+ group and who received neither HPN nor chemotherapy but artificial hydration (AH) was included in the HPN- group. RESULTS: 301 patients were assessed for HPN eligibility and 86 patients (28.6%) were excluded for having severe organ dysfunction or Karnofsky performance status <50. In outcome analysis, 90 patients (29.9%) were excluded for receiving both HPN and chemotherapy, while 125 (41.5%) were included, 89 in HPN+ group (29.5%) and 36 in HPN- group (12%). The survival of the two groups showed a significant difference favouring patients receiving HPN (median overall survival: 4.3 vs 1.5 months, p<0.001). The multivariate analysis of the risk factors for mortality showed that not receiving HPN accounted for the strongest one (HR 25.72, 95% CI 13·65 to 48.44). CONCLUSIONS: Comparative survival associated with the use of HPN versus AH showed significantly longer survival in malnourished patients with advanced cancer receiving HPN. These data support the guideline recommendation that HPN should be considered when malnutrition represents the overriding threat for the survival of these patients.

Comparative Study Regarding the Adherence to the Mediterranean Diet and the Eating Habits of Two Groups-The Romanian Children and Adolescents Living in Nord-West of Romania and Their Romanian Counterparts Living in Italy.

BACKGROUND: The Mediterranean diet (MD) is associated with significant health benefits, including prevention of noncommunicable diseases (NCDs). Given the important migratory flow from Romania to Italy in recent decades, this study seeks to evaluate the differences between the nutritional habits of Romanian children and adolescents in Romania compared with those of Romanian children who moved to Italy or were born in Italy from both Romanian parents. METHOD: To assess adherence to MD, parents of Romanian children in Romania (RCR) and Romanian children in Italy (RCI) answered questions from an adapted version of the KIDMED test. RESULTS: The results show that the high KIDMED index among RCI is significantly higher than the same index among RCR (68.09 versus 17.76, p < 0.05). RCR obtained a higher KIDMED score on different items: they had a lower consumption of fast food and sweets but an increased consumption of nuts, yogurts, and cheese. CONCLUSIONS: RCI have a better adherence to MD, but, at the same time, they are more exposed to westernized diet and practice less physical activity. Nutrition education is an important tool for improving health outcome.

Effectiveness of ketogenic diet in treatment of patients with refractory chronic migraine.

BACKGROUND AND PURPOSE: Ketogenic diet (KD) is based on restriction of carbohydrate intake. Metabolism is forced to obtain energy starting from ß-oxidation of fatty acids which, turned into ketone bodies, can also be used by central nervous system (CNS). KD use in treatment of chronic migraine has recently been considered. We set out to verify modification of symptoms in patients with refractory chronic migraine in response to KD. METHODS: Fifty patients were enrolled of which 38 completed the procedures the study and 23 were considered in the statistics. All of the patients considered in our study were affected by medication overuse headache (MOH). They were on a KD for 3 months. The following parameters have been checked at t = 0 and every 30 days for 6 months: migraine episode length (n. hours/day), frequency (n. days/month), level of pain of every episode measured on a scale from 1 to 3 (1 = mild; 2 = moderate; 3 = severe), and n. analgesic drugs taken/month. RESULTS: Days with symptoms decreased from 30 (median value) to 7.5 with p < 0.0001. The duration of the migraine episodes decreased from 24 h (median value) to 5.5 h with p < 0.0016. The patients' pain level, initially at maximum value for 83% of the participants, improved for 55% of them (p < 0.0024). The number of drugs taken in a month decreased from 30 doses (median value) to 6 doses. CONCLUSIONS: It can be stated that a 3-month KD resulted in a reduction of painful symptoms of drug refractory chronic migraine. This result may suggest an improvement in quality of life of the patients, even without a tabulated data collection.

A Critical Review on the Role of Food and Nutrition in the Energy Balance.

The mass media has increasingly frequently suggested to the general population that specific foods or nutritional schemes are able to affect both human metabolism and energy expenditure, thus facilitating weight loss. This critical review is aimed at assessing available evidence on the roles of nutrients, food and dietary regimens in energy intake and energy expenditure. We queried the National Library of Medicine, the Cochrane Library, Excerpta Medica dataBASEand the Cumulative Index to Nursing and Allied Health Literature database, and a search strategy was performed by using database-specific subject headings and keywords. We found that available scientific evidence on these topics is scarce, and that the limited number of available studies often have poor methodological quality. Only a few foods show beneficial effects on metabolism and energy expenditure, as the human energy balance is complex and multifactorial. Finally, microbiota may interfere with the intake, use and expenditure of energy in the human body. Conclusive evidence is still lacking, and, at present, it is not possible to identify a food or a diet with a significant impact on human energy expenditure.

Role of Bioelectrical Impedance Analysis in the Evaluation of Patients with Upper Limb Lymphedema.

Background: Monofrequency bioelectrical impedance analysis (BIA) protocols seek to further quantify changes in lymphedema compared with traditional circumferential evaluations. Complex decongestive therapy (CDT) is an effective method of reducing unilateral upper limb lymphedema secondary to breast cancer treatments. Comparing lymphedema measurements between segmental tetrapolar BIA, total body BIA, and circumferential measurements during therapeutic changes can improve our quantitative assessment ability for this prevalent medical complication. Methods and Results: Twenty-two patients with breast-cancer-related unilateral upper limb lymphedema participated in this prospective observational study. Circumferential measurements, segmental tetrapolar BIA, and total body BIA were obtained and compared before CDT, immediately after 10 sessions of CDT, and 30 days post-CDT to assess lymphedema. The segmental tetrapolar BIA correlated well with improvements in circumferential measurements of the limb. We found that the resistance value cutoff point of 237 Ω could indicate a recurrence of lymphedema. Conclusions: Segmental, tetrapolar monofrequency BIA provides a simple method to monitor and evaluate the efficacy of therapy in the outpatient setting by operators with minimal training. This protocol could aid quantitative evaluations of unilateral upper limb lymphedema.

Effects of a Synbiotic Formula on Functional Bowel Disorders and Gut Microbiota Profile during Long-Term Home Enteral Nutrition (LTHEN): A Pilot Study.

Long-term enteral nutrition (LTEN) can induce gut microbiota (GM) dysbiosis and gastrointestinal related symptoms, such as constipation or diarrhoea. To date, the treatment of constipation is based on the use of laxatives and prebiotics. Only recently have probiotics and synbiotics been considered, the latter modulating the GM and regulating intestinal functions. This randomized open-label intervention study evaluated the effects of synbiotic treatment on the GM profile, its functional activity and on intestinal functions in long-term home EN (LTHEN) patients. Twenty LTHEN patients were recruited to take enteral formula plus one sachet/day of synbiotic (intervention group, IG) or enteral formula (control group, CG) for four months and evaluated for constipation, stool consistency, and GM and metabolite profiles. In IG patients, statistically significant reduction of constipation and increase of stool consistency were observed after four months (T1), compared to CG subjects. GM ecology analyses revealed a decrease in the microbial diversity of both IC and CG groups. Biodiversity increased at T1 for 5/11 IG patients and Methanobrevibacter was identified as the biomarker correlated to the richness increase. Moreover, the increase of short chain fatty acids and the reduction of harmful molecules have been correlated to synbiotic administration. Synbiotics improve constipation symptoms and influences Methanobrevibacter growth in LTHEN patients.

Vive la Difference! The Effects of Natural and Conventional Wines on Blood Alcohol Concentrations: A Randomized, Triple-Blind, Controlled Study.

Different alcoholic beverages can have different effects on blood alcohol concentration (BAC) and neurotoxicity, even when equalized for alcohol content by volume. Anecdotal evidence suggested that natural wine is metabolized differently from conventional wines. This triple-blind study compared the BAC of 55 healthy male subjects after consuming the equivalent of 2 units of alcohol of a natural or conventional wine over 3 min in two separate sessions, one week apart. BAC was measured using a professional breathalyzer every 20 min after consumption for 2 h. The BAC curves in response to the two wines diverged significantly at twenty minutes (interval T20) and forty minutes (interval T40), and also at their maximum concentrations (peaks), with the natural wine inducing a lower BAC than the conventional wine [T20 = 0.40 versus 0.46 (p < 0.0002); T40 = 0.49 versus 0.53 (p < 0.0015); peak = 0.52 versus 0.56 (p < 0.0002)]. These differences are likely related to the development of different amino acids and antioxidants in the two wines during their production. This may in turn affect the kinetics of alcohol absorption and metabolism. Other contributing factors could include pesticide residues, differences in dry extract content, and the use of indigenous or selected yeasts. The study shows that with the same quantity and conditions of intake, natural wine has lower pharmacokinetic and metabolic effects than conventional wine, which can be assumed due to the different agronomic and oenological practices with which they are produced. It can therefore be hypothesized that the consumption of natural wine may have a different impact on human health from that of conventional wine.

Liver stiffness-based model for portal hypertension and hepatocellular cancer risk in HBV responsive to antivirals.

BACKGROUND: In hepatitis B virus (HBV)-related cirrhosis the antiviral therapy reduces portal hypertension (PH) and risk of hepatocellular carcinoma (HCC). This study assessed the prognostic role of LSPS Score (liver stiffness value X spleen diameter/platelet count) in predicting these goals in cirrhotic patients responsive to antiviral therapy. METHODS: The correlation between LSPS, PH, esophageal varices (EVs) and HCC was evaluated in 121 cirrhotic patients treated with nucleos(t)ide analogues (NUCs). Sixty-one patients (50.4%) had PH at baseline. All were HBV DNA negative on-treatment. They were evaluated after a median of 8 years of therapy (1-17) for LSPS, PH, hepatic venous pressure gradient (HVPG), EVs and HCC. RESULTS: LSPS ≤0.62 and ≤1.4 identified patients without PH measured by HVPG (<6 mmHg, NPV=100%) and EVs (PPV 63.3%, NPV 93.7%), respectively. After antiviral therapy LSPS≤0.62 was detected in 51.3% of the patients (16.4% and 76.6% of subjects with and without PH at baseline, P<0.0001). HCC developed in 26 patients (21.5%, 2.6%-year) with a higher incidence in patients with LSPS>0.62 after antiviral therapy (36% vs. 7%, P<0.001). On multivariate analysis LSPS post-therapy and PH at baseline were the only independent predictors of HCC (OR: 1.18; 95% CI: 1.02-1.28, P=0.02 and OR: 1.70; 95% CI:1-2.86, P=0.04 respectively). CONCLUSIONS: LSPS is useful to identify patients with regression of PH and EVs, avoiding endoscopy. LSPS≤0.62 at baseline or due to antiviral therapy is associated with a lower risk of HCC. Early antiviral treatment is recommended in order to maintain or to induce LSPS≤0.62.

Bioelectrical impedance analysis for monitoring cancer patients receiving chemotherapy and home parenteral nutrition.

BACKGROUND: Home parenteral nutrition (HPN) can improve survival, quality of life, nutritional and functional status in cancer patients. Bioelectrical impedance analysis (BIA) is a non-invasive, validated method to assess body composition. The objective of this prospective single-arm study was to investigate the impact of HPN in advanced cancer patients receiving chemotherapy assessed by BIA, clinical and laboratory measures. METHODS: Adult malnourished cancer outpatients with solid tumors receiving anticancer treatments who were candidates for daily HPN were enrolled. Patients were assessed at baseline (T0), 60 (T1) and 90 days (T2) after HPN start. Assessments included anthropometric and clinical-oncological characteristics, performance status, inflammatory response and Patient-Generated Subjective Global Assessment (PG-SGA). RESULTS: Sixty-five advanced cancer patients were enrolled. Median overall survival was 317 days. Body weight, BMI, oral calorie and protein intake increased over time (P < 0.01). At T2 the proportion of well-nourished patients, Karnofsky performance status and modified Glasgow prognostic score were improved (P < 0.01), total body water was reduced (P = 0.04), and fat mass increased (P = 0.04). Reactance, resistance and phase angle were significantly associated with survival at T0, T1, and T2, respectively. At T2, PG-SGA category A was a predictor of survival (P < 0.0001). CONCLUSIONS: After 90 days of HPN, patients experienced significantly improved nutritional status, performance status, prognostic score and some BIA measures. HPN may be an important therapy in oncology patients receiving chemotherapy. Longitudinal use of BIA may help track the effects of HPN and disease progression, potentially contributing to optimal global patient management.

Effects of Self-Conditioning Techniques (Self-Hypnosis) in Promoting Weight Loss in Patients with Severe Obesity: A Randomized Controlled Trial.

OBJECTIVE: The usefulness of the rapid-induction techniques of hypnosis as an adjunctive weight-loss treatment has not been defined. This randomized controlled trial evaluated whether self-conditioning techniques (self-hypnosis) added to lifestyle interventions contributed to weight loss (primary outcome), changes in metabolic and inflammatory variables, and quality of life (QoL) improvement (secondary outcomes) in severe obesity. METHODS: Individuals (with BMI = 35-50 kg/m2 ) without organic or psychiatric comorbidity were randomly assigned to the intervention (n = 60) or control arm (n = 60). All received exercise and behavioral recommendations and individualized diets. The intervention consisted of three hypnosis sessions, during which self-hypnosis was taught to increase self-control before eating. Diet, exercise, satiety, QoL, anthropometric measurements, and blood variables were collected and measured at enrollment and at 1 year (trial end). RESULTS: A similar weight loss was observed in the intervention (-6.5 kg) and control (-5.6 kg) arms (ß = -0.45; 95% CI: -3.78 to 2.88; P = 0.79). However, habitual hypnosis users lost more weight (-9.6 kg; ß = -10.2; 95% CI: -14.2 to -6.18; P < 0.001) and greatly reduced their caloric intake (-682.5 kcal; ß = -643.6; 95% CI: -1064.0 to -223.2; P = 0.005) in linear regression models. At trial end, the intervention arm showed lower C-reactive protein values (ß = -2.55; 95% CI: -3.80 to -1.31; P < 0.001), higher satiety (ß = 19.2; 95% CI: 7.71-30.6; P = 0.001), and better QoL (ß = 0.09; 95% CI: 0.02-0.16; P = 0.01). CONCLUSIONS: Self-hypnosis was not associated with differences in weight change but was associated with improved satiety, QoL, and inflammation. Indeed, habitual hypnosis users showed a greater weight loss.

Effects of meal timing on changes in circulating epinephrine, norepinephrine, and acylated ghrelin concentrations: a pilot study.

BACKGROUND: Timing of food intake impacts on metabolic diseases. Few data are available about post-meal changes in epinephrine (E), norepinephrine (NE), and acylated ghrelin (AG) at different times of the day. SUBJECTS AND METHODS: This randomized cross-over trial investigated E/NE/AG concentrations after identical meals consumed at 0800 or 2000 hours in 20 healthy volunteers, by standardizing diet, exercise, duration of fast, and resting. Participants randomly received the test meal at 0800 or 2000 hours, and vice versa after 1 week. Blood samples were collected before and up to 180-min post-meal, every 30 min, with participants supine, motionless, but awake. RESULTS: Median E levels increased at 30-60 min, then declined and rose again at 150 min; values at 60 min (19.0 vs. 15.0 ng/l, p = 0.03) and 180 min (25.0 vs. 11.0 ng/l, p < 0.001) were higher after the morning meals. NE rose at 30-60 min and then progressively declined; median values at 60 min (235.3 vs. 206.3 ng/l, p = 0.02) and 120 min (208.8 vs. 142.0 ng/l, p = 0.04) increased more after morning meals. AG progressively declined to increase again at 90 min after meal; median AG area-under-the-curve (AUC) values were lower at morning (7206.8 vs. 8828.3 pg/mL×h). AG-AUC was inversely associated with diet-induced thermogenesis (ß = -121.6; 95% CI -201.0 to 42.2; p = 0.009 for each unit increase), while log NE-AUC was inversely associated with log-triglyceride AUC (ß = -0.57; 95% CI -0.98 to 0.16; p = 0.015) in a multiple regression model, after multiple adjustments. CONCLUSIONS: In conclusion, E/NE concentrations were higher after the morning meal, while AG showed an opposite behavior. These data, although requiring confirmation in larger samples, suggest an adjunctive possible mechanism explaining the unfavorable effects of evening eating on metabolic risk.

Longitudinal study of quality of life in advanced cancer patients on home parenteral nutrition.

Since there is little knowledge regarding the quality of life (QoL) of cancer patients on home parenteral nutrition (HPN), we planned a prospective, longitudinal, double-center study to investigate the changes of QoL in these patients. One hundred and eleven adult cancer patients who were candidates for HPN following the indications of the European guidelines were consecutively enrolled. For QoL analysis, EORTC QLQ-C30 questionnaires were filled at the HPN start and after 1, 2, 3, and 4 months, and scores changes over time were analyzed according to the univariate mixed-effects linear model for repeated measures. Most patients had gastrointestinal cancers, were severely malnourished, and were in stage IV; two-thirds were still receiving oncologic treatments. Median weight loss over 3 months and body mass index were 11.7% and 20.7, respectively. Median survival was 4.7 (1-42) months; 67 and 34% of patients survived 3 and 6 months, respectively. Global QoL, physical functioning, role functioning, emotional functioning, appetite loss, and fatigue scores had a statistically significant trend over time (P < 0.001, P < 0.001, P = 0.007, P < 0.001, P = 0.004, P = 0.022, respectively). At the univariate analyses, the determinants significantly associated with changes in trend over time for physical, role, and emotional functioning were oncologic treatments (P < 0.001, P = 0.014, P = 0.040, respectively) and for appetite loss they were weight loss and Karnofsky performance status (P = 0.003, P = 0.023, respectively). Global QoL, physical, role, and emotional functioning improved during HPN even in advanced cancer patients on oncologic treatments.

Predictive role of the Mediterranean diet on mortality in individuals at low cardiovascular risk: a 12-year follow-up population-based cohort study.

BACKGROUND: Adherence to the Mediterranean diet reduces the risk of all-cause and cardiovascular (CV) mortality and the incidence of CV events. However, most previous studies were performed in high-risk individuals. Our objective was to assess whether the adherence to the Mediterranean diet, evaluated by the MED score, was associated with all-cause and CV mortality and incidence of CV events in individuals at low CV risk from a population-based cohort, after a 12-year mean follow-up. METHODS: A cohort of 1658 individuals completed a validated food-frequency questionnaire in 2001-2003. The MED score was calculated by a 0-9 scale. Anthropometric, laboratory measurements, and the vital status were collected at baseline and during 2014. The baseline CV risk was estimated by the Framingham risk score. Participants were divided into two groups: individuals at low risk (CV < 10) and individuals with CV risk ≥ 10. RESULTS: During a 12-year mean follow-up, 220 deaths, 84 due to CV diseases, and 125 incident CV events occurred. The adherence to the Mediterranean diet was low in 768 (score 0-2), medium in 685 (score 4-5) and high in 205 (score > 6) individuals. Values of BMI, waist circumference, fasting glucose and insulin significantly decreased from low to high diet adherence only in participants with CV risk ≥ 10. In a Cox-regression model, the hazard ratios (HRs) in low-risk individuals per unit of MED score were: HR = 0.83 (95 % CI 0.72-0.96) for all-cause mortality, HR = 0.75 (95 % CI 0.58-0.96) for CV mortality, and HR = 0.79 (95 % CI 0.65-0.97) for CV events, after multiple adjustments. In individuals with CV risk ≥ 10, the MED score predicted incident CV events (HR = 0.85; 95 % CI 0.72-0.99), while the associations with all-cause (HR = 1.02; 95 % CI 0.90-1.15) and CV mortality (0.94; 95 % CI 0.76-1.15) were not significant. CONCLUSIONS: Greater adherence to the Mediterranean diet was associated with reduced fatal and non fatal CV events, especially in individuals at low CV risk, thus suggesting the usefulness of promoting this nutritional pattern in particular in healthier individuals.

Effect of specific educational program on dietary change and weight loss in breast-cancer survivors.

AIMS: Consumption of Western foods with high dietary glycemic load is associated with breast cancer development, whereas adherence to Mediterranean diet has been linked to a reduced risk. Changing lifestyle can decrease risk of recurrences and mortality. Thus decreasing the weight, improving the diet and promoting lifestyle are among of the most important issues of public health. We evaluated the effects of a specific educational intervention conducted by dietitians, nutritionists physicians, oncologist and sport physician to promote lifestyle in breast cancer survivors. METHODS: We recruited 100 pts in breast cancer follow up. The intervention program consisted of four meetings once a week including lectures, training sessions and workshops lasting overall a month. Dietary recommendations were provided on the basis of WCRF/AICR guidelines and were modelled on Mediterranean diet. Sport physician recommended adapted physical activity, based on clinical experiences and scientific evidences. RESULTS: Significantly decrease of BMI and waist circumference was observed after 2 and 6 months. Adherence to Mediterranean diet was significantly improved, both in heightening typical Mediterranean foods, both in decreasing consumption of non typical foods. At baseline 63% of women was inactive, 37% was mild active and 0% active, while at the end inactive patients felt by half (30%) and mild active women almost doubled (67%). CONCLUSIONS: We found this dietary intervention effective in reducing BMI and waist circumference, and enhancing healthy lifestyle in BC survivors. It has surely contributed to achieve these results besides the change in diet quality, mostly a marked reduction in sedentary habits.

Dietary flavonoid intake and cardiovascular risk: a population-based cohort study.

BACKGROUND: The cardio-protective effects of flavonoids are still controversial; many studies referred to the benefits of specific foods, such as soy, cocoa, tea. A population-based cohort of middle-aged adults, coming from a semi-rural area where the consumption of those foods is almost negligible, was studied. AIMS: The primary objective was establishing if flavonoid intake was inversely associated with the cardiovascular (CV) risk evaluated after 12-year follow-up; the associations between flavonoid intake and CV incidence and mortality and all-cause mortality were also evaluated. METHODS: In 2001-2003, a cohort of 1,658 individuals completed a validated food-frequency questionnaire. Anthropometric, laboratory measurements, medical history and the vital status were collected at baseline and during 2014. The CV risk was estimated with the Framingham risk score. RESULTS: Individuals with the lowest tertile of flavonoid intake showed a worse metabolic pattern and less healthy lifestyle habits. The 2014 CV risk score and the increase in the risk score from baseline were significantly higher with the lowest intake of total and all subclasses of flavonoids, but isoflavones, in a multiple regression model. During follow-up, 125 CV events and 220 deaths (84 of which due to CV causes) occurred. CV non-fatal events were less frequent in individuals with higher flavonoid intake (HR = 0.64; 95%CI 0.42-1.00 and HR = 0.46; 95%CI 0.28-0.75 for the second and third tertiles, respectively) in Cox-regression models, after multiple adjustments. All subclasses of flavonoids, but flavones and isoflavones, were inversely correlated with incident CV events, with HRs ranging from 0.42 (flavan-3-ols) to 0.56 (anthocyanidins). Being in the third tertile of flavan-3-ols (HR = 0.68; 95% CI 0.48-0.96), anthocyanidins (HR = 0.66; 95% CI 0.46-0.95) and flavanones (HR = 0.59; 95% CI 0.40-0.85) was inversely associated with all-cause mortality. Total and subclasses of flavonoids were not significantly associated with the risk of CV mortality. CONCLUSIONS: Flavonoid intake was inversely associated with CV risk, CV non-fatal events and all-cause mortality in a cohort with a low consumption of soy, tea and cocoa, which are typically viewed as the foods responsible for flavonoid-related benefits.

Consuming more of daily caloric intake at dinner predisposes to obesity. A 6-year population-based prospective cohort study.

BACKGROUND/OBJECTIVES: It has been hypothesized that assuming most of the caloric intake later in the day leads to metabolic disadvantages, but few studies are available on this topic. Aim of our study was to prospectively examine whether eating more of the daily caloric intake at dinner leads to an increased risk of obesity, hyperglycemia, metabolic syndrome, and non-alcoholic fatty liver disease (NAFLD). SUBJECTS/METHODS: 1245 non-obese, non-diabetic middle-aged adults from a population-based cohort underwent a 3-day food record questionnaire at enrollment. Anthropometric values, blood pressure, blood metabolic variables, and estimated liver fat were measured at baseline and at 6-year follow-up. DESIGN: Prospective cohort study. RESULTS: Subjects were divided according to tertiles of percent daily caloric intake at dinner. A significant increase in the incidence rate of obesity (from 4.7 to 11.4%), metabolic syndrome (from 11.1 to 16.1%), and estimated NAFLD (from 16.5 to 23.8%) was observed from the lower to higher tertile. In a multiple logistic regression model adjusted for multiple covariates, subjects in the highest tertile showed an increased risk of developing obesity (OR = 2.33; 95% CI 1.17-4.65; p = 0.02), metabolic syndrome (OR = 1.52; 95% CI 1.01-2.30; p = 0.04), and NAFLD (OR = 1.56; 95% CI 1.10-2.22; p = 0.01). CONCLUSIONS: Consuming more of the daily energy intake at dinner is associated with an increased risk of obesity, metabolic syndrome, and NAFLD.

Prospective randomized trial: endoscopic follow up 3 vs 6 months after esophageal variceal eradication by band ligation in cirrhosis.

BACKGROUND AND OBJECTIVES: Endoscopic variceal ligation (EVL) is recommended to treat esophageal varices (EV) in cirrhosis and portal hypertension. A program of endoscopic surveillance is not clearly established. The aim of this prospective randomized trial was to assess the most effective timing of endoscopic monitoring after variceal eradication and its impact on the patient's outcome and on the costs. METHODS: A hundred and two cirrhotic patients with esophageal varices treated by EVL were evaluated. After variceal eradication patients were randomized to receive first endoscopic control at 3 (Group 1) and 6 (Group 2) months respectively. RESULTS: Variceal obliteration was achieved in all patients. Variceal recurrence was observed in 28 cases at the first control (29.1%) without difference between the two groups (32% vs 29% in group 1 and 2 respectively, p=0.75). The incidence of large varices is similar in the two groups (33% vs 38% respectively). Using a multivariate analysis, medical therapy with B blockers was the only independent predictor of lowest risk of variceal recurrence [OR 2.30, 95% CI (1.68-3.26)]. Bleeding related to recurrent varices occurred in 3.1% of cases and was associated with portal thrombosis. Child Pugh score ≥8 was the only predictor of mortality (p=0.0002). CONCLUSIONS: Recurrence of varices after banding ligation is not rare but it is associated with a low risk of variceal progression and bleeding. Accordingly, a first endoscopic control at 6 months after variceal eradication associated with a good risk stratification might be a cost-effective strategy of monitoring.

Antibiotics and non-steroidal anti-inflammatory drugs in outpatient practice: indications and unwanted effects in a gastroenterological setting.

OBJECTIVE: To explore the type and frequency of the unwanted effects following use of non-steroidal antiinflammatory drugs (NSAIDs) and antibiotics in a gastroenterological out-patient setting. METHODS: We analyzed a gastroenterological database which includes 151 inflammatory bowel disease (IBD) patients followed between January 2008 and December 2009. The key-words included NSAIDs and antibiotics. RESULTS: Of 19 cases treated with NSAIDs, 8 displayed convincing evidence linking them with the subsequent development of IBD. Of 44 antibiotic mentions, 7 documents alluded to macrolide prescriptions, which were followed by induction or relapse of IBD in 5; all of the newly diagnosed cases of IBD were endoscopically proven, and one ran a fulminant course requiring emergency colectomy; 4 of 5 prescriptions of amoxycillin/clavulanic acid were accompanied by toxicity (three hepatitides and one reactivated IBD). Overall, the frequency of unwanted effects was 36% for both NSAIDs and antibiotics. CONCLUSION: We suggest that NSAIDs and antibiotics (specifically of the macrolide structure) can induce gut and hepatic damage, significantly enhancing co-morbidities in gastroenterologic out-patients, with break of cost-containment guidelines. Therefore, caution is advisable in prescribing NSAIDs and antibiotics in this setting. Though retrospective and possibly biased, the current data coincide with both bench work and epidemiological evidence.