Effect of Polyphenol-rich Dark Chocolate on Insulin Sensitivity in Normal Weight and Overweight...
Insulin ResistanceThe purpose of the study is to determine the effect of polyphenol-rich dark chocolate on insulin sensitivity in normal weight and overweight adults.
Evaluating the Effectiveness of a Handbook for Parents of Children Newly Diagnosed With Food Allergy...
HypersensitivityFoodThe objective of this research is to evaluate the effectiveness of a handbook for parents of children newly diagnosed with food allergy. The handbook was developed to provide information and strategies to support families in effectively managing food allergies while maintaining positive quality of life. Parents of children newly diagnosed with food allergy (within the past year) will be randomized into either the treatment condition (handbook) or a control condition (management of food allergy as usual). Participants will complete study questionnaires online at three time points: baseline (this will be before receiving the handbook for the treatment group), post-intervention (2-3 weeks after baseline), and follow-up (2-3 months after baseline). Data will be analyzed for change on study outcome measures and satisfaction with the handbook. Parents in the control group will receive the handbook following the conclusion of their participation in the study.
Influence of the Immunosystem in Non-celiac Glutensensitivity
Gluten SensitivityPatients with non-celiac gluten sensitivity (NCGS) complain about gastrointestinal and extraintestinal symptoms while consuming gluten-containing cereals. The symptoms strictly correlate with ingestion of gluten-containing cereals and disappear quickly under elimination diets. Till now, there are no specific markers to diagnose NCGS. This study aims to determine the effect of a low FODMAP diet (fermentable oligo-, di- and monosaccharides and polyols) and a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being. Furthermore, the influence of the diets on the microbiome will be analyzed.
Integrated Approaches to Food Allergen and Allergy Risk Management
Food AllergyPatients with history of a food allergy to hazelnut, walnut or celeriac will undergo food provocation with a dose of the allergenic food to which 5% of the respective food allergic population (ED05) has been calculated to respond with allergic reactions (single shot study). In patients with a hazelnut or peanut allergy a double-blind placebo controlled food challenge with cookies containing either placebo or hazelnut and peanut respectively will be performed to determine threshold levels eliciting an allergic reaction. The results for threshold levels determined by cookie matrix will be compared to the results gained from the EuroPrevall project (matrix comparison study). In patients with a walnut allergy double-blind placebo controlled provocation with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on the threshold level and on the clinical manifestation.
Study to Evaluate the Potential of Air Structuring Protein to Elicit Allergic Reactions in Mold...
Allergy to MoldAir Structuring Protein (ASP) is a small protein derived from a fungus which is already widely used to produce enzymes that are added to foods. ASP has the possibility of stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential ice-cream ingredient. Toxicological tests have also been carried out to further confirm the safety of the material and no evidence of genotoxicity or acute toxicity has been observed in any of the tests. As part of the safety evaluation of a new protein for use in foods, the potential allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect of ASP. This study will investigate: Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population of participants with proven sensitivity to mould. Whether ASP is responsible for any positive SPT reactions, should they occur. And if any positive SPT reactions to ASP occur, whether such reactions are clinically relevant with respect to food allergy. The study is divided in three stages. In Stage 1 and Stage 2, the SPT is "open label," which means that both the participant and the study doctor will know which materials are being tested. In Stage 3, the food challenge has a "crossover" design, meaning that participants will take one of the products (ASP or placebo [food containing no ASP]) during the first half of the study and the other treatment during the second half. The order of ASP and placebo will be decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair as possible, the food challenge is "double blinded." This means that neither the participant nor the study doctor will know which kind of products (ASP or placebo) the participant is taking. This is a multi centre study which is taking place in the UK.
The Effect of Lowered Physical Activity on Insulin Sensitivity and Lipid and Glucose Metabolism...
Insulin SensitivityThe purpose of this study is to investigate the effects of lowered physical activity (resulting in decreased muscle mitochondrial oxidative capacity) alone and together with increased plasma free fatty acid availability (by infusion of a clinically widely used lipid emulsion (Intralipid)) on insulin sensitivity and glucose and lipid metabolism. To this end, we will compare skeletal muscle insulin sensitivity and glucose and lipid metabolism (within one subject) after 9 days of immobilization of one leg (unilateral lower limb suspension(ULLS))(decreased muscle mitochondrial oxidative capacity) versus an active control leg (unchanged muscle mitochondrial oxidative capacity). Further, changes in IMCL and fatty acid intermediates will be investigated in the immobilized vs the control leg, and this will be related to insulin sensitivity. The effectiveness of the ULLS intervention will be tested by measuring muscle mitochondrial oxidative capacity in both the immobilized and the control leg. All measurements will be performed both in the immobilized and control leg after 9 days of ULLS.
Specific Oral Tolerance Induction to Cow's Milk Allergy
Food HypersensitivityBackground: Limited published evidence shows specific oral tolerance induction (SOTI) to be a potential intervention option for cow's milk proteins (CMPs) allergy. Our hypothesis is that SOTI should be started early in order to improve its efficacy and prevent CMPs sensitization from evolving towards persistent allergy. The aim of this study was to evaluate the safety and efficacy of SOTI in 2-year-old children with cow's milk allergy, as a treatment alternative to elimination diet. Methods: A total of 60 children between 24-36 months of age with IgE-mediated allergy to CMPs were included in this multicenter study and were randomly divided into two different groups. Thirty children (group A: treatment group) began SOTI immediately, whereas the remaining 30 (group B: control group) were kept on a milk-free diet and followed-up on for one year.
A Phase I/IIa Study to Evaluate the Safety, Tolerability and Efficacy of Topical LTX-109 in Subjects...
Nasal Carriers MRSAThis is a pilot study conducted to evaluate the safety, local tolerability and efficacy of LTX-109(Lytixar™), a lytic peptide designed to kill bacterias quickly and efficient. LTX-109 (Lytixar™)will be applied in the anterior nares in subjects who are carriers of nasal colonies of MRSA/MSSA. The extent of systemic absorption of LTX -109 when applied to the anterior nares will be evaluated and the effect of Lytixar™ as to clear colonies of MRSA/MSSA during the the observation period and Week 2 to Week 9 after treatment.
Tolerability of ALK Tree Tablet
AllergyThis trial is performed to assess the tolerability of the ALK Tree Tablet in patients with birch pollen induced allergy
Identification of Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy...
Ragweed AllergyThe aim of the study is to identify changes in potential biomarkers after peptide immunotherapy for that may subsequently be developed as biomarkers that correlate with clinical efficacy.