Development and validation of the MY-VEG-FFQ: A modular web-based food-frequency questionnaire for vegetarians and vegans.

BACKGROUND AND OBJECTIVE: The adoption of plant-based diets in recent years has increased the need for accurate assessments of dietary intake among vegans, vegetarians, semi-vegetarians, and omnivores. This study aimed at developing and validating a modular web-based food-frequency questionnaire (FFQ), the MY-VEG-FFQ. This FFQ was based on the original FFQ (O-FFQ) designed for the Israeli population and incorporates a skip algorithm tailored for different dietary patterns. METHODS: A convenience sample of 101 participants, recruited via social media, completed the MY-VEG FFQ, as well as a three-day food records, which served as the gold standard for this research. Relative validity of the new FFQ was evaluated by comparing nutrients with those in the three-day food records, using Pearson correlation coefficients, Bland-Altman plots, and cross-classification. The results were compared with 90 O-FFQs that previously had been completed by vegans. RESULTS: The validation analysis showed that nutrient-intake estimates were generally higher for the MY-VEG-FFQ than those of the three-day food records. Pearson correlation coefficients ranged between 0.25-0.63, indicating an acceptable agreement between the two tools. The proportion of participants with exact or adjacent quartile agreement was between 73%-82%. The Bland-Altman analysis revealed overestimation of nutrient intake via the MY-VEG-FFQ. Compared to the O-FFQ, vegans who completed the MY-VEG-FFQ reported consumption of more food items. Additionally, the MY-VEG-FFQ showed a significantly higher intake of most macro- and micronutrients. CONCLUSIONS: The My-VEG-FFQ demonstrated reasonable validity in assessing dietary intake among people who followed a plant-based diet. However, it tended to overestimate nutrient intake compared to the three-day food records. The development of a modular web-based FFQ with a skip algorithm tailored for specific dietary patterns, fills a crucial gap in accurately assessing the dietary intake of these populations. The MY-VEG-FFQ offers a practical and cost-effective tool for evaluating long-term dietary consumption among people who follow different dietary patterns.

Ultra-processed food (UPF) intake in pregnancy and maternal and neonatal outcomes.

PURPOSE: Ultra-processed food (UPF), as defined by the NOVA classification, is related to lower diet quality, which may adversely affect maternal health and neonatal outcomes. This study aims to describe nutrient intake of pregnant women by the share of UPF in the diet and to identify associations between UPF intake and maternal and neonatal outcomes. METHODS: In this cross-sectional study, pregnant women (n = 206) were recruited upon arrival to the obstetrics ward for delivery, and asked to complete a Food Frequency Questionnaire (FFQ), and questionnaires regarding environmental exposures, and socio-demographic characteristics. Neonatal measurements and clinical data were obtained following delivery. UPF energy intake was expressed as absolute and in terms of percent from total energy. Women with high intake of energy from UPF were compared to those with low intake. RESULTS: Among 206 pregnant women, dietary intake of UPF ranged from 15.6% to 43.4% of total energy in the first and fourth quartiles of UPF consumption, respectively. Women in the fourth quartile of energy from UPF had lower intakes of vitamin C, beta-carotene, vitamin B6, and potassium, which is indicative of inferior diet quality. Percent energy from UPF was associated with maternal obesity (BMI ≥ 30) (OR = 1.06, 95% CI: 1.06, 1.10, p = 0.008) and shorter male infant ano-genital distance (AGD) (B = -1.9, 95% CI: -3.5, -0.24, p = 0.02). CONCLUSIONS: UPF intake during pregnancy is associated with undesirable maternal and neonatal outcomes and more research is needed to confirm these findings.

Oncology Treatments during the COVID-19 Pandemic in Israel: the ONCOR Study.

BACKGROUND: The increased susceptibility of cancer patients to coronavirus disease-2019 (COVID-19) infections and complications calls for special precautions while treating cancer patients during COVID-19 pandemics. Thus, oncology departments have had to implement a wide array of prevention measures. OBJECTIVES: To address issues associated with cancer care during the COVID-19 pandemic and to assess the implementation of measures aimed at containment of COVID-19 diffusion while allowing continuation of quality cancer care. METHODS: A national survey among oncology departments in Israel was conducted between 12 April 2020 and 14 April 2020. Eighteen heads of hospital-based oncology departments completed a self-report questionnaire regarding their institute's preparedness for treatment of cancer patients during the COVID-19 pandemic. RESULTS: In this national survey, prevention measures against COVID-19 spread were taken prior to patients' arrival and at arrival or while staying in the departments. Most participants (78-89%) reported using a quick triage of patients and caregivers prior to their entrance to the oncology units, limiting the entrance of caregivers, and reducing unnecessary visits to the clinic. Switching to oral therapies rather than intravenous ones when possible was considered by 82% and shortage in personal protective equipment was reported by five (28%) heads of oncology departments. Some differences between large and small/medium sized medical centers were observed regarding issues related to COVID-19 containment measures and changes in treatment. CONCLUSIONS: Oncology departments in Israel were able to prepare and adapt their services to guidelines and requirements related to the COVID-19 pandemic with little harm to their treatment capacity.

Breast cancer survivors: physical and mental quality of life 10 years following diagnosis, a case-control study.

PURPOSE: Improvements in diagnosis and treatment of Breast Cancer (BC) have resulted in an increase in the life expectancy of survivors and in the importance of quality of life in BC survivorship care. The current study aimed to assess the Health-Related Quality Of Life (HRQOL) of BC survivors and to investigate the association of comorbidities with HRQOL compared to a group of women with no history of cancer. METHODS: Women were residents of the central district in Israel, the case group included 250 women diagnosed with BC between 1999 and 2003, with no prior cancer history and no evidence of disease after 8-12 years. The comparison group included 250 women with no cancer history, individually matched to cases by age and area of residence. Data were collected through in-person interviews, and HRQOL was assessed using the Short Form-36 (SF-36) questionnaire. Regression analyses were performed evaluating the influence of demographic, socioeconomic, lifestyle characteristics and comorbidities on physical and mental HRQOL. RESULTS: The physical and mental summary scores means, were 48.5 ± 11.1 and 49.2 ± 10.8 compared to 51.5 ± 10.2 and 50.9 ± 10.6, in BC survivors and the comparison group, respectively (p = 0.002 and p = 0.097). BC survivors and controls did not differ in number and type of comorbidities and for both groups a negative association was seen with HRQOL. Controlling for age, income, number of comorbidities, BMI and physical activity, BC survivor had decreased physical (b = -2.49, p = 0.001) and mental summary scores (b = -1.27, p = 0.18). CONCLUSION: HRQOL of BC survivors should gain more attention in the area of cancer care, especially when comorbidities are present.

ApoE Genotype, Lipid Profile, Exercise, and the Associations With Cardiovascular Morbidity and 18-Year Mortality.

BACKGROUND: Studies of longevity examined apolipoprotein E (ApoE), a gene involved in lipoprotein metabolism, which interacts with susceptibility to age-related diseases, and with mortality. We evaluated the association of ApoE isoforms with cardiovascular disease (CVD) and all-cause mortality. METHODS: A prospective cohort of 949 survivors of the Israel Study of Glucose Intolerance, Obesity, and Hypertension, examined during 1999-2004, mean age 72 years, was followed for mortality until 2017. Participants were interviewed for lifestyle habits and medical history. Anthropometrics and biochemical markers were taken. Logistic regression was used to assess CVD morbidity and Cox proportional hazard model for mortality. RESULTS: The most common genotype in the cohort was ApoE E3 (76.3%), with the other two almost equally distributed (ApoE E2 11.2% and ApoE E4 12.5%). In men only, ApoE E4 associated with CVD (adjusted odds ratio = 1.46, 95% confidence interval [CI] 0.76, 2.80) and with 18-year mortality (adjusted hazard ratio = 1.47, 95% CI 0.95, 2.26), adjusting for age, ethnicity, physical activity, hypertension, diabetes, low-density lipoprotein (LDL)-cholesterol, high-density lipoprotein (HDL)-cholesterol, triglycerides and lipid-lowering medications. Low levels of HDL cholesterol, adjusted for ApoE and the above-mentioned variables, associated with higher prevalence of CVD (adjusted odds ratio = 1.35, 95% CI 1.00, 1.83) and all-cause mortality (adjusted hazard ratio = 1.42, 95% CI 1.14, 1.78). ApoE E3 and E2 conferred a lower 18-year mortality risk in the physically active individuals, compared to the sedentary (adjusted hazard ratio = 0.57, 95% CI 0.44, 0.74, and adjusted hazard ratio = 0.53, 95% CI 0.78, 1.02, respectively). CONCLUSIONS: In community-dwelling older adults, sociodemographic characteristics and physical activity, blood pressure and HDL-cholesterol levels, may outweigh the impact of ApoE polymorphisms on CVD morbidity and all-cause mortality.

Effect of wine on carotid atherosclerosis in type 2 diabetes: a 2-year randomized controlled trial.

BACKGROUND/OBJECTIVES: The progression of carotid-plaque volume in patients with type 2 diabetes is common. Previous observational studies showed an association between moderate alcohol and reduced risk of coronary disease. We examined whether consuming moderate wine affects the progression of carotid atherosclerosis. SUBJECTS/METHODS: In the CASCADE (CArdiovaSCulAr Diabetes and Ethanol), a 2-year randomized controlled trial, we randomized abstainers with type 2 diabetes were to drink 150 ml of either red wine, white wine, or water, provided for 2 years. In addition, groups were guided to maintain a Mediterranean diet. We followed 2-year changes in carotid total plaque volume (carotid-TPV) and carotid vessel wall volume (carotid-VWV), using three-dimensional ultrasound. RESULTS: Carotid images were available from 174 of the 224 CASCADE participants (67% men; age = 59 yr; HbA1C = 6.8%). Forty-five percent had detectable plaque at baseline. After 2 years, no significant progression in carotid-TPV was observed (water, -1.4 (17.0) mm3, CI (-2.7, 5.5), white-wine, -1.2 (16.9) mm3, CI (-3.8, 6.2), red wine, -1.3 (17.6) mm3, CI (-3.4, 6.0; p = 0.9 between groups)). In post hoc analysis, we divided the 78 participants with detectable baseline carotid plaque into tertiles. Those with the higher baseline plaque burden, whom were assigned to drink wine, reduced their plaque volume significantly after 2 years, as compared to baseline. Two-year reductions in Apo(B)/Apo(A) ratio(s) were independently associated with regression in carotid-TPV (ß = 0.4; p < 0.001). Two-year decreases in systolic blood pressure were independently associated with regression in carotid-VWV (ß = 0.2; p = 0.005). CONCLUSIONS: No progression in carotid-TPV was observed. In subgroup analyses, those with the greatest plaque burden assigned to drink wine may have had a small regression of plaque burden.

Dietary Therapy With the Crohn's Disease Exclusion Diet is a Successful Strategy for Induction of Remission in Children and Adults Failing Biological Therapy.

BACKGROUND: Loss of response [LoR] to biologics in Crohn's disease [CD] is a significant clinical problem. Dietary therapy as a treatment strategy in this setting has not been previously reported. We report the use of dietary strategies using enteral nutrition coupled with the Crohn's Disease Exclusion Diet [CDED] for LoR to infliximab or adalimumab as a single-centre experience. METHODS: Patients with LoR to a biologic despite dose escalation or combination therapy were treated with partial enteral nutrition [PEN] by a polymeric formula and the CDED for 12 weeks. Paediatric patients with severe flares received 14 days of exclusive enteral nutrition followed by PEN + CDED as above. All patients were seen at weeks 6 and 12 for follow up. Current and prior treatment, Harvey Bradshaw Index [HBI], C-reactive protein [CRP] and albumin were recorded. Remission was defined as HBI <5 at week 6. RESULTS: Twenty-one patients, mean age 22.1 ± 8.9 years [11 adults and ten children] met study criteria. Seventeen patients [81%] had used combination therapy, and 10/21 [47.6%] had failed a second biologic. Seven patients had a prior intestinal resection. Dose escalation had failed in 13/21 [62%] patients. Clinical remission by physician's global assessment and HBI after 6 weeks was obtained in 13/21 [61.9%]. Mean HBI decreased from 9.4 ± 4.2 to 2.6 ± 3.8 [p < 0.001], mean CRP decreased from 2.8 ± 3.4 to 0.7 ± 0.5 [p = 0.005] and mean albumin increased from 3.5 ± 0.6 to 3.8 ± 0.5 [p = 0.06]. CONCLUSION: Dietary treatment combining PEN with the CDED may be a useful salvage regimen for patients failing biological therapy despite dose escalation.

Effects of initiating moderate wine intake on abdominal adipose tissue in adults with type 2 diabetes: a 2-year randomized controlled trial.

OBJECTIVE: To generate evidence-based conclusions about the effect of wine consumption on weight gain and abdominal fat accumulation and distribution in patients with type 2 diabetes. DESIGN: In the 2-year randomized controlled CASCADE (CArdiovaSCulAr Diabetes & Ethanol) trial, patients following a Mediterranean diet were randomly assigned to drink 150 ml of mineral water, white wine or red wine with dinner for 2 years. Visceral adiposity and abdominal fat distribution were measured in a subgroup of sixty-five participants, using abdominal MRI. SETTING: Ben-Gurion University of the Negev, Soroka-Medical Center and the Nuclear Research Center Negev, Israel. SUBJECTS: Alcohol-abstaining adults with well-controlled type 2 diabetes. RESULTS: Forty-eight participants (red wine, n 27; mineral water, n 21) who completed a second MRI measurement were included in the 2-year analysis. Similar weight losses (sd) were observed: red wine 1·3 (3·9) kg; water 1·0 (4·2) kg (P=0·8 between groups). Changes (95 % CI) in abdominal adipose-tissue distribution were similar: red wine, visceral adipose tissue (VAT) -3·0 (-8·0, 2·0) %, deep subcutaneous adipose tissue (DSAT) +5·2 (-1·1, 11·6) %, superficial subcutaneous adipose tissue (SSAT) -1·9 (-5·0, 1·2) %; water, VAT -3·2 (-8·9, 2·5) %, DSAT +2·9 (-2·8, 8·6) %, SSAT -0·15 (-3·3, 2·9) %. No changes in antidiabetic medication and no substantial changes in energy intake (+126 (sd 2889) kJ/d (+30·2 (sd 690) kcal/d), P=0·8) were recorded. A 2-year decrease in glycated Hb (ß=0·28, P=0·05) was associated with a decrease in VAT. CONCLUSIONS: Moderate wine consumption, as part of a Mediterranean diet, in persons with controlled diabetes did not promote weight gain or abdominal adiposity.

Effects of Initiating Moderate Alcohol Intake on Cardiometabolic Risk in Adults With Type 2 Diabetes: A 2-Year Randomized, Controlled Trial.

BACKGROUND: Recommendations for moderate alcohol consumption remain controversial, particularly in type 2 diabetes mellitus (T2DM). Long-term randomized, controlled trials (RCTs) are lacking. OBJECTIVE: To assess cardiometabolic effects of initiating moderate alcohol intake in persons with T2DM and whether the type of wine matters. DESIGN: 2-year RCT (CASCADE [CArdiovaSCulAr Diabetes & Ethanol] trial). (ClinicalTrials.gov: NCT00784433). SETTING: Ben-Gurion University of the Negev-Soroka Medical Center and Nuclear Research Center Negev, Israel. PATIENTS: Alcohol-abstaining adults with well-controlled T2DM. INTERVENTION: Patients were randomly assigned to 150 mL of mineral water, white wine, or red wine with dinner for 2 years. Wines and mineral water were provided. All groups followed a Mediterranean diet without caloric restriction. MEASUREMENTS: Primary outcomes were lipid and glycemic control profiles. Genetic measurements were done, and patients were followed for blood pressure, liver biomarkers, medication use, symptoms, and quality of life. RESULTS: Of the 224 patients who were randomly assigned, 94% had follow-up data at 1 year and 87% at 2 years. In addition to the changes in the water group (Mediterranean diet only), red wine significantly increased high-density lipoprotein cholesterol (HDL-C) level by 0.05 mmol/L (2.0 mg/dL) (95% CI, 0.04 to 0.06 mmol/L [1.6 to 2.2 mg/dL]; P < 0.001) and apolipoprotein(a)1 level by 0.03 g/L (CI, 0.01 to 0.06 g/L; P = 0.05) and decreased the total cholesterol-HDL-C ratio by 0.27 (CI, -0.52 to -0.01; P = 0.039). Only slow ethanol metabolizers (alcohol dehydrogenase alleles [ADH1B*1] carriers) significantly benefited from the effect of both wines on glycemic control (fasting plasma glucose, homeostatic model assessment of insulin resistance, and hemoglobin A1c) compared with fast ethanol metabolizers (persons homozygous for ADH1B*2). Across the 3 groups, no material differences were identified in blood pressure, adiposity, liver function, drug therapy, symptoms, or quality of life, except that sleep quality improved in both wine groups compared with the water group (P = 0.040). Overall, compared with the changes in the water group, red wine further reduced the number of components of the metabolic syndrome by 0.34 (CI, -0.68 to -0.001; P = 0.049). LIMITATION: Participants were not blinded to treatment allocation. CONCLUSION: This long-term RCT suggests that initiating moderate wine intake, especially red wine, among well-controlled diabetics as part of a healthy diet is apparently safe and modestly decreases cardiometabolic risk. The genetic interactions suggest that ethanol plays an important role in glucose metabolism, and red wine's effects also involve nonalcoholic constituents. PRIMARY FUNDING SOURCE: European Foundation for the Study of Diabetes.

Viraemia suppressed in HIV-1-infected humans by broadly neutralizing antibody 3BNC117.

HIV-1 immunotherapy with a combination of first generation monoclonal antibodies was largely ineffective in pre-clinical and clinical settings and was therefore abandoned. However, recently developed single-cell-based antibody cloning methods have uncovered a new generation of far more potent broadly neutralizing antibodies to HIV-1 (refs 4, 5). These antibodies can prevent infection and suppress viraemia in humanized mice and nonhuman primates, but their potential for human HIV-1 immunotherapy has not been evaluated. Here we report the results of a first-in-man dose escalation phase 1 clinical trial of 3BNC117, a potent human CD4 binding site antibody, in uninfected and HIV-1-infected individuals. 3BNC117 infusion was well tolerated and demonstrated favourable pharmacokinetics. A single 30 mg kg(-1) infusion of 3BNC117 reduced the viral load in HIV-1-infected individuals by 0.8-2.5 log10 and viraemia remained significantly reduced for 28 days. Emergence of resistant viral strains was variable, with some individuals remaining sensitive to 3BNC117 for a period of 28 days. We conclude that, as a single agent, 3BNC117 is safe and effective in reducing HIV-1 viraemia, and that immunotherapy should be explored as a new modality for HIV-1 prevention, therapy and cure.

Bottle and sippy cup use is associated with diet and energy intake in toddlers.

The second year of life incorporates a continued shift from a liquid- to solid-based diet. Little is known about the prevalence and dietary impact of bottle and sippy cup use. This paper describes associations between percent of energy consumed via drinking containers (bottles and sippy cups combined) and dietary outcomes, between 1 and 2 years of age. This observational study recruited n = 299 low-income, nutrition programme clients from the Bronx, NY, whose 12 month olds consumed ≥ 2 non-water bottles per day. The main exposure variable was percent of energy intake via drinking containers (PEDC), dichotomized at the median into low-percent-energy-from-drinking-containers (LOW-C) and high-percent-energy-from-drinking-containers (HIGH-C) groups, assessed quarterly, for 1 year. We report 24-hour dietary recall nutrient and food serving data by LOW-C vs. HIGH-C. We employed linear mixed models to study associations between PEDC and nutrient intake. PEDC decreased from 52% to 33% between 1 and 2 years of age in both groups. The LOW-C group had higher intake of energy, dietary fibre, iron and sodium, grains, protein-rich foods and sweets. Conversely, LOW-C group had lower intake of Vitamin D and calcium vs. the HIGH-C group. PEDC was inversely associated with total energy intake in a model controlling for baseline age, baseline-weight-for-length and gender (ß = -5.8, P = 0.029, 95% confidence interval (-10.96, -0.6). Lower bottle and sippy cup use had significant, albeit mixed association with diet quality in the second year of life, and was associated with higher energy intake. Evidence-based guidelines are needed to determine the appropriate use of those feeding methods.

Abdominal superficial subcutaneous fat: a putative distinct protective fat subdepot in type 2 diabetes.

OBJECTIVE: Unlike visceral adipose tissue (VAT), the association between subcutaneous adipose tissue (SAT) and obesity-related morbidity is controversial. In patients with type 2 diabetes, we assessed whether this variability can be explained by a putative favorable, distinct association between abdominal superficial SAT (SSAT) (absolute amount or its proportion) and cardiometabolic parameters. RESEARCH DESIGN AND METHODS: We performed abdominal magnetic resonance imaging (MRI) in 73 patients with diabetes (mean age 58 years, 83% were men) and cross-sectionally analyzed fat distribution at S1-L5, L5-L4, and L3-L2 levels. Patients completed food frequency questionnaires, and subgroups had 24-h ambulatory blood pressure monitoring and 24-h ambulatory electrocardiography. RESULTS: Women had higher %SSAT (37 vs. 23% in men; P < 0.001) despite a similar mean waist circumference. Fasting plasma glucose (P = 0.046) and HbA(1c) (P = 0.006) were both lower with increased tertile of absolute SSAT. In regression models adjusted for age, waist circumference, and classes of medical treatments used in this patient population, increased %SSAT was significantly associated with decreased HbA(1c) (ß = -0.317; P = 0.013), decreased daytime ambulatory blood pressure (ß = -0.426; P = 0.008), and increased HDL cholesterol (ß = 0.257; P = 0.042). In contrast, increased percent of deep SAT (DSAT) was associated with increased HbA(1c) (ß = 0.266; P = 0.040) and poorer heart rate variability parameters (P = 0.030). Although total fat and energy intake were not correlated with fat tissue distribution, increased intake of trans fat tended to be associated with total SAT (r = 0.228; P = 0.05) and DSAT (r = 0.20; P = 0.093), but not with SSAT. CONCLUSIONS: Abdominal SAT is composed of two subdepots that associate differently with cardiometabolic parameters. Higher absolute and relative distribution of fat in abdominal SSAT may signify beneficial cardiometabolic effects in patients with type 2 diabetes.

Dietary strategies for patients with type 2 diabetes in the era of multi-approaches; review and results from the Dietary Intervention Randomized Controlled Trial (DIRECT).

Dietary intervention is recognized as a key component in prevention and management of type 2 diabetes (T2DM) and the debate persists: which dietary strategy is most effective. In the Dietary Intervention Randomized Controlled Trial (DIRECT) 322 moderately obese participants were randomized for 2 years to one of three diet groups: low-fat, Mediterranean and low-carbohydrate. Differential effects were observed in the sub-group of patients with T2DM at 24 months: participants randomized to the Mediterranean diet, which had the highest intake of dietary fibers and unsaturated to saturated fat ratio, achieved greater significant improvements in fasting plasma glucose and insulin levels. Patients who were randomized to the low-carbohydrate diet, which had the minimal intake of carbohydrates, achieved a significant reduction of hemoglobin A1C. Although improvements were observed in all groups, the low-fat diet was likely to be less beneficial in terms of glycemic control and lipid metabolism. Interpretation of results from different studies on dietary strategies may be complex since there is often no consistency in diet compositions, calorie restriction, intensity of intervention, dietary assessment or extent of adherence in the trial. Nevertheless, it seems that low fat restricted calorie diets are effective for weight loss and are associated with some metabolic benefits; however, some recent trials have shown that low carbohydrate diets are as efficient in inducing weight loss and in some metabolic measures such as serum triglycerides and HDL-cholesterol may be even superior to low fat diets. When addressing the issue of diet quality rather than quantity applying the glycemic index may have some added benefits. Furthermore special features of the Mediterranean diet have apparent additional favorable effects for patients with T2DM.