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Tolerance induction through non-avoidance to prevent persistent food allergy (TINA) in children and adults with peanut or tree nut allergy: rationale, study design and methods of a randomized controlled trial and observational cohort study
Background
Peanuts (PN) and tree nuts (TN) are among the most frequent elicitors of food allergy and can lead to life-threatening reactions. The current advice for allergic patients is to strictly avoid the offending food independently of their individual threshold level, whereas sensitized patients without allergic symptoms should frequently consume the food to avoid (re-)development of food allergy. The aim of this trial is to investigate (I) whether the consumption of low allergen amounts below the individual threshold may support natural tolerance development and (II) to what extent regular allergen consumption in sensitized but tolerant subjects prevents the (re-)development of PN or TN allergy.
Methods
The TINA trial consisting of (part I) a randomized, controlled, open, parallel group, single-center, superiority trial (RCT), and (part II) a prospective observational exploratory cohort study. Children and adults (age 1–67 years) with suspected or known primary PN and/or TN allergy will undergo an oral food challenge (OFC) to determine their clinical reactivity and individual threshold. In the RCT, 120 PN or TN allergic patients who tolerate ≥100 mg of food protein will be randomized (1:1 ratio) to consumption of products with low amounts of PN or TN on a regular basis or strict avoidance for 1 year. The consumption group will start with 1/100 of their individual threshold, increasing the protein amount to 1/50 and 1/10 after 4 and 8 months, respectively. The primary endpoint is the clinical tolerance to PN or TN after 1 year assessed by OFC. In the cohort study, 120 subjects sensitized to PN and/or TN but tolerant are advised to regularly consume the food and observed for 1 year. The primary endpoint is the maintenance of clinical tolerance to PN and/or TN after 1 year assessed by challenging with the former tolerated cumulative dose.
Discussion
This clinical trial will help to determine the impact of allergen consumption versus avoidance on natural tolerance development and whether the current dietary advice for PN or TN allergic patients with higher threshold levels is still valid.
Trial registration
German Clinical Trials Register; ID:
DRKS00016764
(RCT),
DRKS00020467
(cohort study). Registered on 15 January 2020,
http://www.drks.de
.
Journal Article
Tree Nut Allergy in Children—What Do We Know? —A Review
Food allergy represents a significant public health concern, with its prevalence increasing in recent decades. Tree nuts are among major allergenic foods, and allergies to them are frequently linked to severe and potentially life-threatening reactions. Data on the prevalence and natural history of tree nut allergy are limited. Primary nut allergy typically presents with rapid-onset IgE-mediated symptoms. Diagnosis can be confirmed by demonstrating a positive skin prick test (SPT), specific IgE (sIgE), or through an oral food challenge. Component-resolved diagnostics (CRD) can identify those with a high risk of anaphylaxis. The main management strategy involves avoiding the culprit allergen and treating symptoms after accidental exposure. New therapeutic options, such as sublingual immunotherapy, oral food immunotherapy, with or without omalizumab, and other monoclonal antibodies, are being investigated to modify tree nut allergy. Tree nut allergy is a lifelong disease with a low likelihood of resolution. The aim of this paper is to present the current data on the prevalence, diagnosis, natural history, and management options for tree nut allergy.
Journal Article
We need more nuts!
A little squirrel counts as he tosses nuts, one at a time, into a bigger squirrel's mouth until he discovers that it is possible to have enough.
Book
Tree nut phytochemicals: composition, antioxidant capacity, bioactivity, impact factors. A systematic review of almonds, Brazils, cashews, hazelnuts, macadamias, pecans, pine nuts, pistachios and walnuts
Tree nuts contain an array of phytochemicals including carotenoids, phenolic acids, phytosterols and polyphenolic compounds such as flavonoids, proanthocyanidins (PAC) and stilbenes, all of which are included in nutrient databases, as well as phytates, sphingolipids, alkylphenols and lignans, which are not. The phytochemical content of tree nuts can vary considerably by nut type, genotype, pre- and post-harvest conditions, as well as storage conditions. Genotype affects phenolic acids, flavonoids, stilbenes and phytosterols, but data are lacking for many other phytochemical classes. During the roasting process, tree nut isoflavones, flavanols and flavonols were found to be more resistant to heat than the anthocyanins, PAC and trans-resveratrol. The choice of solvents used for extracting polyphenols and phytosterols significantly affects their quantification, and studies validating these methods for tree nut phytochemicals are lacking. The phytochemicals found in tree nuts have been associated with antioxidant, anti-inflammatory, anti-proliferative, antiviral, chemopreventive and hypocholesterolaemic actions, all of which are known to affect the initiation and progression of several pathogenic processes. While tree nut phytochemicals are bioaccessible and bioavailable in humans, the number of intervention trials conducted to date is limited. The objectives of the present review are to summarise tree nut: (1) phytochemicals; (2) phytochemical content included in nutrient databases and current publications; (3) phytochemicals affected by pre- and post-harvest conditions and analytical methodology; and (4) bioactivity and health benefits in humans.
Journal Article
The Nuts : keep rolling!
Hazel and Wally want to be big and tall so they start rolling, picking up mud and goo that makes them seem bigger but leads to a series of problems they can avoid only if they keep rolling.
Book
Mixed Nut Challenge Test (MixNut) as an Efficient Procedure in the Management of Lipid Transfer Protein Allergy
: Lipid transfer protein (LTP) syndrome is a leading cause of primary food allergy in Mediterranean countries, often associated with severe reactions. Due to in vitro cross-reactivity among plant foods, clinical manifestations are unpredictable, frequently requiring multiple oral food challenges (OFC) to assess nut tolerance. These procedures increase healthcare burden and patient anxiety. This study evaluated the safety and utility of a mixed-nut oral food challenge (MixNut) in LTP-sensitized patients.
: In this prospective observational multi-center study, patients with LTP syndrome were enrolled. Group A included individuals allergic to fruits or vegetables who had avoided nuts; Group B included patients with suspected or confirmed nut allergy. Participants underwent a MixNut challenge comprising 2-4 nuts (≥3 g protein per nut).
: Nineteen patients (73.7% male; median age 32.5 years) underwent MixNut, testing 52 individual nuts. All challenges were negative. The MixNut approach reduced the number of OFC by 63% (from 52 to 19) and total testing time from 208 to 76 h. Specific IgE levels to LTP allergens (Pru p 3, Cor a 8, Ara h 9) varied widely and did not predict clinical reactivity.
: MixNut is an efficient diagnostic tool for LTP syndrome, significantly reducing testing time, costs, and patient burden. It facilitates accurate dietary management and prevents unnecessary food avoidance. Further studies should optimize MixNut protocols and identify predictive markers for clinical reactivity.
Journal Article
Please, no more nuts!
Tired of eating nuts morning, noon, and night, a squirrel desperately tries to get rid of his excess stash.
Book
Efficacy of cashew nut protein immunotherapy: protocol for a single-centre randomised controlled trial in a Polish paediatric population
IntroductionThe prevalence of food allergies, particularly IgE-mediated allergies, is rising in developed countries, with cashew nut allergy emerging as a significant public health concern due to its potential for severe anaphylaxis and frequent association with atopic disorders. Cashew nuts are among the most common allergens in Europe and Australia, often involving cosensitisation with pistachios, hazelnuts and other allergens. Diagnosis relies on clinical history, measurement of specific IgE (sIgE) levels, skin prick tests (SPT) and oral food challenges (OFCs). Current management strategies focus on allergen avoidance and emergency interventions, whereas oral immunotherapy (OIT) represents a promising approach to desensitisation. Recent studies, including the NUT CRACKER trial, have reported high desensitisation rates with cashew OIT, although these are associated with a risk of adverse events. This study introduces a novel randomised controlled trial aimed at evaluating the efficacy and safety of cashew immunotherapy in children.Methods and analysisThis randomised, open-label, parallel-group trial, with a 2:1 allocation ratio, will be conducted at the Department of Paediatric Pneumology and Allergology, Medical University of Warsaw, Poland. Thirty-nine children, aged 4–17 years, with confirmed IgE-mediated cashew allergy via open OFC will be enrolled. Participants in the experimental group will undergo OIT, which involves gradually increasing doses of cashew protein up to a maintenance dose of 1200 mg. The duration of OIT will range from 12 to 60 weeks, depending on individual baseline tolerance. The control group will receive standard management, including strict cashew avoidance and emergency response strategies to accidental exposure, for 1 year.The primary endpoint is to determine the proportion of participants tolerating a 4043 mg dose of cashew protein at the study’s end in the OIT group compared with the control group. Secondary outcomes include evaluating the safety profile of OIT, assessing changes in laboratory markers such as sIgE and IgG4 levels for cashew and the major cashew allergen Ana o 3, analysing basophil activation test responses and measuring changes in SPT wheal diameter at baseline and study completion.Ethics and disseminationThe study has been approved by the Ethics Committee of the Medical University of Warsaw (approval number: KB/267/2023). Study findings will be published in peer-reviewed journals and presented at international conferences.Trial registration numberNCT06328504.
Journal Article