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How does dose impact on the severity of food-induced allergic reactions, and can this improve risk assessment for allergenic foods?: Report from an ILSI Europe Food Allergy Task Force Expert Group and Workshop.
Dubois, AEJ, Turner, PJ, Hourihane, J, Ballmer-Weber, B, Beyer, K, Chan, CH, Gowland, MH, O'Hagan, S, Regent, L, Remington, B, et al
Allergy. 2018;(7):1383-1392
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Abstract
Quantitative risk assessment (QRA) for food allergens has made considerable progress in recent years, yet acceptability of its outcomes remains stymied because of the limited extent to which it has been possible to incorporate severity as a variable. Reaction severity, particularly following accidental exposure, depends on multiple factors, related to the allergen, the host and any treatments, which might be administered. Some of these factors are plausibly still unknown. Quantitative risk assessment shows that limiting exposure through control of dose reduces the rates of reactions in allergic populations, but its impact on the relative frequency of severe reactions at different doses is unclear. Food challenge studies suggest that the relationship between dose of allergenic food and reaction severity is complex even under relatively controlled conditions. Because of these complexities, epidemiological studies provide very limited insight into this aspect of the dose-response relationship. Emerging data from single-dose challenges suggest that graded food challenges may overestimate the rate of severe reactions. It may be necessary to generate new data (such as those from single-dose challenges) to reliably identify the effect of dose on severity for use in QRA. Success will reduce uncertainty in the susceptible population and improve consumer choice.
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Increasing low-energy-dense foods and decreasing high-energy-dense foods differently influence weight loss trial outcomes.
Vadiveloo, M, Parker, H, Raynor, H
International journal of obesity (2005). 2018;(3):479-486
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Abstract
BACKGROUND/OBJECTIVE Although reducing energy density (ED) enhances weight loss, it is unclear whether all dietary strategies that reduce ED are comparable, hindering effective ED guidelines for obesity treatment. This study examined how changes in number of low-energy-dense (LED) (<4.186 kJ/1.0 kcal g-1) and high-energy-dense (HED) (>12.56 kJ/3.0 kcal g-1) foods consumed affected dietary ED and weight loss within an 18-month weight loss trial. METHODS This secondary analysis examined data from participants randomized to an energy-restricted lifestyle intervention or lifestyle intervention plus limited non-nutrient dense, energy-dense food variety (n=183). Number of daily LED and HED foods consumed was calculated from three, 24-h dietary recalls and anthropometrics were measured at 0, 6 and 18 months. Multivariable-adjusted generalized linear models and repeated-measures mixed linear models examined associations between 6-month changes in number of LED and HED foods and changes in ED, body mass index (BMI), and percent weight loss at 6 and 18 months. RESULTS Among mostly female (58%), White (92%) participants aged 51.9 years following an energy-restricted diet, increasing number of LED foods or decreasing number of HED foods consumed was associated with 6- and 18-month reductions in ED (β=-0.25 to -0.38 kJ g-1 (-0.06 to -0.09 kcal g-1), P<0.001). Only increasing number of LED foods consumed was associated with 6- and 18-month reductions in BMI (β=-0.16 to -0.2 kg m-2, P<0.05) and 6-month reductions in percent weight loss (β=-0.5%, P<0.05). Participants consuming ⩽2 HED foods per day and ⩾6.6 LED foods per day experienced better weight loss outcomes at 6- and 18-month than participants only consuming ⩽2 HED foods per day. CONCLUSION Despite similar reductions in ED from reducing number of HED foods or increasing number of LED foods consumed, only increasing number of LED foods related to weight loss. This provides preliminary evidence that methods used to reduce dietary ED may differentially influence weight loss trajectories. Randomized controlled trials are needed to inform ED recommendations for weight loss.
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A Default Option to Enhance Nutrition Within Financial Constraints: A Randomized, Controlled Proof-of-Principle Trial.
Coffino, JA, Hormes, JM
Obesity (Silver Spring, Md.). 2018;(6):961-967
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Abstract
OBJECTIVE This study aimed to examine the feasibility and initial efficacy of a novel default option intervention targeting nutritional quality of online grocery purchases within the financial constraints of food insecurity. METHODS Female undergraduates (n = 59) without eating disorder symptoms or dietary restrictions selected foods online with a budget corresponding to maximum Supplemental Nutrition Assistance Program benefits. Before completing the task again, participants were randomly assigned to receive a $10 incentive for selecting nutritious groceries (n = 17), education about nutrition (n = 24), or a default online shopping cart containing a nutritionally balanced selection of groceries (n = 18) to which they could make changes. Nutritional quality was quantified by using the Thrifty Food Plan Calculator. RESULTS Compared with the education condition, participants in the default condition selected significantly more whole grains and fruits and foods lower in cholesterol, saturated fats, sodium, and overall calories. There were no statistically significant differences in nutritional outcomes between the incentive condition and the other two groups. CONCLUSIONS Findings provide initial support for the efficacy of a default option in facilitating healthier food choice behaviors within financial constraints.
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Oral food challenge using different target doses and time intervals between doses.
Yanagida, N, Sato, S, Nagakura, KI, Asaumi, T, Ebisawa, M
Current opinion in allergy and clinical immunology. 2018;(3):222-227
Abstract
PURPOSE OF REVIEW The oral food challenge (OFC) is a specific and vital tool used in clinical practice to identify the level of tolerance a person exhibits toward certain foods while diagnosing food-related allergies. OFC methods differ among countries. The aim of this review is to evaluate different target doses and determine the time interval between doses used for OFC. RECENT FINDINGS We analyzed recent articles on target doses and time between doses, and noted that some papers reported low target doses and less time between doses. A low-dose OFC appears to be a useful strategy; a time interval of 15 min between doses is short and that of at least 1 h is appropriate. SUMMARY Low-dose OFCs appear to be well tolerated and effective to avoid complete elimination of the consumption of foods causing allergies. For the safety of the OFC method, the time interval between doses should be more than 30 min.
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The absolute bioavailability and the effect of food on a new magnesium lactate dihydrate extended-release caplet in healthy subjects.
Dogterom, P, Fu, C, Legg, T, Chiou, YJ, Brandon, S
Drug development and industrial pharmacy. 2018;(9):1481-1487
Abstract
OBJECTIVE To assess the absolute bioavailability of 20 mEq magnesium lactate extended-release (ER) caplets and to assess the effect of food on the pharmacokinetics of these ER caplets. SIGNIFICANCE Magnesium in different salt forms is available as over-the-counter oral formulations. The absorption and bioavailability is highly affected by the water solubility of the salt form. A new ER caplet of 10 mEq strength of magnesium L-lactate dihydrate has been developed to increase the bioavailability of magnesium. METHODS An open label, single-dose, randomized, three-period, cross-over study in healthy adults was conducted with three treatments: (a) single oral dose of 20 mEq magnesium L-lactate dehydrate under fasting conditions, (b) single intravenous (IV) infusion of 20 mEq magnesium sulfate, and (c) single oral dose of 20 mEq magnesium L-lactate dehydrate under fed conditions. Urine and blood samples were collected for analysis of urinary and serum magnesium concentrations. RESULTS Absolute bioavailabilities of the caplets under fasted and fed conditions, compared to IV magnesium sulfate, were 20.26% (fasted) and 12.49% (fed) in serum, based on the geometric mean ratio (GMR) of the baseline-adjusted AUC0-72, and 38.11% (fasted) and 40.99% (fed) in urine, based on the GMR of the baseline-adjusted Ae0-72. Relative bioavailability of the caplets comparing the fed and fasted states was 61.67% in serum, based on the GMR of the baseline-adjusted AUC0-72, and 107.57% in urine, based on the GMR of the baseline-adjusted Ae0-72. CONCLUSIONS This new magnesium formulation has reasonable bioavailability and might be a valuable addition to the currently available magnesium oral products.
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The Inflammatory Potential of Dietary Manganese in a Cohort of Elderly Men.
Kresovich, JK, Bulka, CM, Joyce, BT, Vokonas, PS, Schwartz, J, Baccarelli, AA, Hibler, EA, Hou, L
Biological trace element research. 2018;(1):49-57
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Abstract
Manganese is an essential nutrient that may play a role in the production of inflammatory biomarkers. We examined associations between estimated dietary manganese intake from food/beverages and supplements with circulating biomarkers of inflammation. We further explored whether estimated dietary manganese intake affects DNA methylation of selected genes involved in the production of these biomarkers. We analyzed 1023 repeated measures of estimated dietary manganese intakes and circulating blood inflammatory biomarkers from 633 participants in the Normative Aging Study. Using mixed-effect linear regression models adjusted for covariates, we observed positive linear trends between estimated dietary manganese intakes and three circulating interleukin proteins. Relative to the lowest quartile of estimated intake, concentrations of IL-1β were 46% greater (95% CI - 5, 126), IL-6 52% greater (95% CI - 9, 156). and IL-8 32% greater (95% CI 2, 71) in the highest quartiles of estimated intake. Estimated dietary manganese intake was additionally associated with changes in DNA methylation of inflammatory biomarker-producing genes. Higher estimated intake was associated with higher methylation of NF-κβ member activator NKAP (Q4 vs Q1: β = 3.32, 95% CI - 0.6, 7.3). When stratified by regulatory function, higher manganese intake was associated with higher gene body methylation of NF-κβ member activators NKAP (Q4 vs Q1: β = 10.10, 95% CI - 0.8, 21) and NKAPP1 (Q4 vs Q1: β = 8.14, 95% CI 1.1, 15). While needed at trace amounts for various physiologic functions, our results suggest estimated dietary intakes of manganese at levels slightly above nutritional adequacy contribute to inflammatory biomarker production.
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Estimation of the Power of the Food Effect on QTc to Show Assay Sensitivity.
Ferber, G, Fernandes, S, Täubel, J
Journal of clinical pharmacology. 2018;(1):81-88
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The most recent International Conference on Harmonisation E14 Q&A document states that a separate positive control would not be necessary provided sufficiently high exposures are achieved in the early-phase studies. Realistically, a phase 1 study is unlikely to include a pharmacological positive control, and in cases in which plasma levels of the drug exceeding therapeutic levels are not achieved, the lack of a positive control can constitute a limitation when excluding an effect of regulatory concern. It has been proposed to use the effect of a standardized meal on the estimate of the diurnal time course of QTc to show assay sensitivity. We conducted simulations by subsampling subjects from a 3 different studies and could show that the effect on food on QTc can be reliably prove assay sensitivity for sample sizes as low as 3 × 6 subjects with a power greater than 80%.
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How to manage food dependent exercise induced anaphylaxis (FDEIA).
Asaumi, T, Ebisawa, M
Current opinion in allergy and clinical immunology. 2018;(3):243-247
Abstract
PURPOSE OF REVIEW In recent years, the number of reports on food-dependent exercise-induced anaphylaxis (FDEIA) has been increasing. This review aims to describe the standard management of FDEIA including provocation tests and identify the issues that remain unclear. RECENT FINDINGS Provocation tests with aspirin for FDEIA enable us to confirm the definitive diagnosis and to make differential diagnosis. In some cases, FDEIA symptoms can be induced by aspirin and the causative food without exercise. Exercise may only be an augmenting factor of FDEIA, similar to aspirin or alcohol. SUMMARY The mechanisms of FDEIA development remain unclear. It has been suggested that in FDEIA, exercise lowers the threshold of a food allergy. Further research is needed to elucidate the mechanism of FDEIA and to establish strategies for effective disease management.
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IgE sensitization to food allergens and airborne allergens in relation to biomarkers of type 2 inflammation in asthma.
Patelis, A, Alving, K, Middelveld, R, James, A, Ono, J, Ohta, S, Izuhara, K, Borres, MP, Forsberg, B, Janson, C, et al
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology. 2018;(9):1147-1154
Abstract
BACKGROUND We have recently reported that sensitization to food allergens and sensitization to airborne allergens had independent associations with increased fraction of exhaled nitric oxide (FeNO) and blood eosinophils in middle-aged adults and in young subjects with asthma. OBJECTIVE To investigate the relation between IgE sensitization and several type 2 inflammation biomarkers in adult asthmatics. METHODS FeNO, urinary eosinophil-derived neurotoxin (U-EDN), serum eosinophil cationic protein (S-ECP) and periostin were measured in 396 asthmatics, aged 17-76 years, from the Swedish GA2LEN study. Sensitization to airborne allergens was examined with skin prick tests (≥3 mm wheal) and sensitization to food allergens with measurement of specific IgE (≥0.35 kU/L). RESULTS Asthmatics sensitized to food allergens had higher FeNO, 22.3 ppb (18.6, 26.7) vs 16.1 ppb (14.2, 18.2) (P = .005), S-ECP, 17.7 mg/L (14.8, 21.1) vs 12.8 mg/L (10.9, 14.9) (P = .01), and periostin, 73.7 (67.5, 80.3) ng/mL vs 59.9 (55.8, 64.2) ng/mL (P = .003), than non-sensitized subjects. Periostin levels in this group were also significantly higher than in the group sensitized only to airborne allergens (P = .01). Sensitization to food allergens related independently to FeNO (P = .02), S-ECP (P = .006) and periostin (P = .004), whereas sensitization only to airborne allergens related only to FeNO (P = .02) after adjustments for age, sex, height, weight and smoking history. FeNO correlated weakly with S-ECP (r = .17, P < .001), periostin (r = .19, P < .001) and U-EDN (0.16, P < .001). S-ECP also correlated weakly with U-EDN (r = .12, P = .02). None of the correlations between the remaining pairs of markers of type 2 inflammation were significant. CONCLUSIONS & CLINICAL RELEVANCE Sensitization to food allergens related to several local and systemic type 2 inflammation markers, such as FeNO, S-ECP and periostin. Assessing the profile of allergic sensitization, including to food allergens, might improve the understanding and interpretation of inflammatory markers and potentially improve asthma management.
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Death by food.
Byard, RW
Forensic science, medicine, and pathology. 2018;(3):395-401
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Abstract
Although death from food is not an uncommon finding in forensic facilities worldwide, the range of underlying lethal mechanisms and associated conditions that should be sought at the time of autopsy is quite disparate. Deaths may occur from i) infectious agents including bacteria, viruses, protozoa, cestodes, nematodes and prions; ii) natural toxins including amanita toxins, tetrodotoxin, ciguatera and scombroid; iii) anaphylaxis; iv) poisoning; v) mechanical issues around airway and gut obstruction and/or perforation; and vi) miscellaneous causes. Food-related deaths are important in terms of global mortality, and thus autopsies need to be comprehensive with full ancillary testing. Medicolegal matters may involve issues concerning likely exposure to infectious agents, possible foods ingested, the declared content and possible components of food, the significance of toxicological analyses, and aspects of duty of care in cases of café coronary syndrome and gastroenteritis while in care.