Browsing by Author "Azevedo, LF"
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- Allergen Immunotherapy in MASK‐Air Users in Real‐Life: Results of a Bayesian Mixed‐Effects ModelPublication . Sousa‐Pinto, B; Azevedo, LF; Sá‐Sousa, A; Vieira, RJ; Amaral, R; Klimek, L; Czarlewski, W; Anto, JM; Bedbrook, A; Kvedariene, V; Ventura, MT; Ansotegui, IJ; Bergmann, KC; Brussino, L; Canonica, GW; Cardona, V; Carreiro‐Martins, P; Casale, T; Cecchi, L; Chivato, T; Chu, DK; Cingi, C; Costa, EM; Cruz, AA; De Feo, G; Devillier, P; Fokkens, WJ; Gaga, M; Gemicioğlu, B; Haahtela, T; Ivancevich, JC; Ispayeva, Z; Jutel, M; Kuna, P; Kaidashev, I; Kraxner, H; Larenas‐Linnemann, DE; Laune, D; Lipworth, B; Louis, R; Makris, M; Monti, R; Morais‐Almeida, M; Mösges, R; Mullol, J; Odemyr, M; Okamoto, Y; Papadopoulos, NG; Patella, V; Pham‐Thi, N; Regateiro, FS; Reitsma, S; Rouadi, PW; Samolinski, B; Sova, M; Todo‐Bom, A; Taborda‐Barata, L; Tomazic, PV; Toppila‐Salmi, S; Sastre, J; Tsiligianni, I; Valiulis, A; Wallace, D; Waserman, S; Yorgancioglu, A; Zidarn, M; Zuberbier, T; Fonseca, JA; Bousquet, J; Pfaar, OBackground: Evidence regarding the effectiveness of allergen immunotherapy (AIT) on allergic rhinitis has been provided mostly by randomised controlled trials, with little data from real-life studies. Objective: To compare the reported control of allergic rhinitis symptoms in three groups of users of the MASK-air® app: those receiving sublingual AIT (SLIT), those receiving subcutaneous AIT (SCIT), and those receiving no AIT. Methods: We assessed the MASK-air® data of European users with self-reported grass pollen allergy, comparing the data reported by patients receiving SLIT, SCIT and no AIT. Outcome variables included the daily impact of allergy symptoms globally and on work (measured by visual analogue scales-VASs), and a combined symptom-medication score (CSMS). We applied Bayesian mixed-effects models, with clustering by patient, country and pollen season. Results: We analysed a total of 42,756 days from 1,093 grass allergy patients, including 18,479 days of users under AIT. Compared to no AIT, SCIT was associated with similar VAS levels and CSMS. Compared to no AIT, SLIT-tablet was associated with lower values of VAS global allergy symptoms (average difference = 7.5 units out of 100; 95% credible interval [95%CrI] = -12.1;-2.8), lower VAS Work (average difference = 5.0; 95%CrI = -8.5;-1.5), and a lower CSMS (average difference = 3.7; 95%CrI = -9.3;2.2). When compared to SCIT, SLIT-tablet was associated with lower VAS global allergy symptoms (average difference = 10.2; 95%CrI = -17.2;-2.8), lower VAS Work (average difference = 7.8; 95%CrI = -15.1;0.2), and a lower CSMS (average difference = 9.3; 95%CrI = -18.5;0.2). Conclusion: In patients with grass pollen allergy, SLIT-tablet, when compared to no AIT and to SCIT, is associated with lower reported symptom severity. Future longitudinal studies following internationally-harmonised standards for performing and reporting real-world data in AIT are needed to better understand its 'real-world' effectiveness.
- Can Wheat Germ Have a Beneficial Effect on Human Health? A Study Protocol for a Randomised Crossover Controlled Trial to Evaluate its Health EffectsPublication . Moreira-Rosário, A; Pinheiro, H; Calhau, C; Azevedo, LFINTRODUCTION: Cardiovascular diseases (CVD) are the leading cause of mortality worldwide and diet is an important contributor to CVD risk. Thus, several food derivatives are being investigated for their beneficial impact on reducing cardiometabolic risk factors, either in risk groups or in healthy population as a preventive measure. Wheat germ is a food by-product with high nutritional value, especially as a concentrated source of dietary fibre and essential fatty acids, but its incorporation into the diet has been rare up to now. Previous studies do not clarify the hypothesised potential causal relationship between the consumption of wheat germ and benefits for human health. METHODS AND ANALYSIS: We are conducting a randomised, double-blinded, crossover, placebo-controlled clinical trial designed to assess the physiological effects of daily consumption of wheat germ-enriched bread (containing 6 g of wheat germ) compared with non-enriched bread, over a 4-week period with a 15-week follow-up, in a healthy human population. A total of 55 participants (healthy volunteers, aged 18-60) have been recruited from the Porto metropolitan area in northern Portugal. Our aim is to evaluate the health effects of wheat germ on blood cholesterol and triglycerides, postprandial glycaemic response, gastrointestinal function and discomfort, and changes in intestinal microbiota and insulin resistance as secondary outcomes. The study follows the best practices for evaluating health claims in food according to the European Food Safety Authority (EFSA) scientific opinion, namely random allocation, double blinding, reporting methods to measure and maximise compliance, and validated outcomes with beneficial physiological effects as recommended by EFSA. ETHICS AND DISSEMINATION: The study has been approved by the Health Ethics Committee of São João Hospital Centre (156-15) and the Ethics Committee of Faculty of Medicine of the University of Porto (PCEDCSS-FMUP07/2015). Results will be disseminated through peer-reviewed publications and presentations at international scientific meetings.
- Daily Intake of Wheat Germ-Enriched Bread May Promote a Healthy Gut Bacterial Microbiota: a Randomised Controlled TrialPublication . Moreira-Rosário, A; Marques, C; Pinheiro, H; Norberto, S; Sintra, D; Teixeira, JA; Calhau, C; Azevedo, LFPurpose: Wheat bran fibre has a beneficial effect on gastrointestinal function, but evidence for wheat germ is scarce. Accordingly, we evaluated the effects of daily intake of wheat germ on gastrointestinal discomfort and gut microbiota by adding wheat germ to refined (white) wheat bread, the most consumed bread type. We hypothesised that an improvement in the composition of refined bread could beneficially affect intestinal health without compromising consumers' acceptance. Methods: Fifty-five healthy adults were recruited for a randomised, double-blind, crossover, controlled trial comprising two 4-week intervention periods separated by a 5-week washout stage. During the first 4-week period, one group consumed wheat bread enriched with 6 g of wheat germ and the control group consumed non-enriched wheat bread. Results: Wheat germ-enriched bread was well-appreciated and the number of participants that demonstrated minimal gastrointestinal improvements after wheat-germ intake was higher than in the control arm. Importantly, intake of wheat germ-enriched bread decreased the perceived gastrointestinal discomfort-related quality of life (subscale worries and concerns) over refined white bread. The improvements in the gastrointestinal function were accompanied by favourable changes in gut microbiota, increasing the number of Bacteroides spp. and Bifidobacterium spp. Conclusions: Adding wheat germ to industrially made white bread without altering sensory properties may promote a healthy gut bacterial microbiota and the gastrointestinal health.
- Does Intake of Bread Supplemented with Wheat Germ Have a Preventive Role on Cardiovascular Disease Risk Markers in Healthy Volunteers? A Randomised, Controlled, Crossover TrialPublication . Moreira-Rosário, A; Pinheiro, H; Marques, C; Teixeira, JA; Calhau, C; Azevedo, LFOBJECTIVE: Intake of whole grains is associated with a reduced risk of cardiovascular disease (CVD). This evidence is also strong for bran alone, but findings about germ are conflicting. Our aim was to elucidate the role of germ in primary prevention of cardiovascular events, and therefore, a staple food was selected for 6 g of germ supplementation. This corresponds to sixfold increase in the global mean consumption of germ, while preserving the sensory proprieties of refined bread which is crucial for consumer's acceptance. DESIGN: Randomised, double-blinded, crossover, controlled clinical trial with 15-week follow-up comprising a 2-week run-in, two intervention periods of 4 weeks each and a 5-week washout period. SETTING: A single centre in the north of Portugal. PARTICIPANTS: 55 eligible healthy adults (mean age of 34 years and body mass index between 19 and 38 kg/m2) were randomly assigned. INTERVENTIONS: The study consisted of two intervention periods including daily intake of refined wheat bread enriched with 6 g of wheat germ and control (non-enriched bread). OUTCOMES: Changes in fasting cholesterol and triglycerides, fasting and postprandial glucose, insulin sensitivity and C reactive protein. RESULTS: We observed no significant effect of daily intake of wheat germ on cholesterol and triglycerides levels, on postprandial glucose response and on insulin sensitivity. Incremental area under curve glucose and homeostasis model assessment for insulin resistance did not change, suggesting that 6 g of wheat germ have no effect on glucose metabolism. No effect was also observed in the subgroup of participants who complied with the protocol (n=47). CONCLUSIONS: The absence of alterations on lipid and glucose profiles suggests that germ up to 6 g/day may have no preventive effect on CVD risk. However, it is important to investigate other food vehicles that can accommodate higher doses of wheat germ in future studies.
- Portuguese Version of the Pain Beliefs and Perceptions Inventory: a Multicenter Validation StudyPublication . Azevedo, LF; Sampaio, R; Dias, C; Romão, J; Lemos, L; Agualusa, L; Vaz-Serra, S; Patto, T; Costa-Pereira, A; Castro-Lopes, JMBackground: We aimed to perform the translation, cultural adaptation, and validation of the Pain Beliefs and Perceptions Inventory (PBPI) for the European Portuguese language and chronic pain population. Methods: This is a longitudinal multicenter validation study. A Portuguese version of the PBPI (PBPI-P) was created through a process of translation, back translation, and expert panel evaluation. The PBPI-P was administered to a total of 122 patients from 13 chronic pain clinics in Portugal, at baseline and after 7 days. Internal consistency and test-retest reliability were assessed by Cronbach's alpha (α) and intraclass correlation coefficient (ICC). Construct (convergent and discriminant) validity was assessed based on a set of previously developed theoretical hypotheses about interrelations between the PBPI-P and other measures. Exploratory and confirmatory factor analyses were performed to test the theoretical structure of the PBPI-P. Results: The internal consistency and test-retest reliability coefficients for each respective subscale were α = 0.620 and ICC = 0.801 for mystery; α = 0.744 and ICC = 0.841 for permanence; α = 0.778 and ICC = 0.791 for constancy; and α = 0.764 and ICC = 0.881 for self-blame. Exploratory and confirmatory factor analysis revealed a four-factor structure (performance, constancy, self-blame, and mystery) that explained 63% of the variance. The construct validity of the PBPI-P was shown to be adequate, with more than 90% of the previously defined hypotheses regarding interrelations with other measures confirmed. Conclusion: The PBPI-P has been shown to be adequate and to have excellent reliability, internal consistency, and validity. It may contribute to a better pain assessment and is suitable for research and clinical use.