First-in-Human Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single Doses of NTM-1633, a Novel Mixture of Monoclonal Antibodies against Botulinum Toxin E.

Botulism is a rare, life-threatening paralytic disease caused by botulinum neurotoxin (BoNT). Available treatments including an equine antitoxin and human immune globulin are given postexposure and challenging to produce and administer. NTM-1633 is an equimolar mixture of 3 human IgG monoclonal antibodies, E1, E2, and E3, targeting BoNT serotype E (BoNT/E). This first-in-human study assessed the safety, tolerability, pharmacokinetics (PK), and immunogenicity of NTM-1633. This double-blind, single-center, placebo-controlled dose escalation study randomized 3 cohorts of healthy volunteers to receive a single intravenous dose of NTM-1633 (0.033, 0.165, or 0.330 mg/kg) or saline placebo. Safety monitoring included physical examinations, clinical laboratory studies, and vital signs. Blood sampling was performed at prespecified time points for PK and immunogenicity analyses. Twenty-four subjects received study product (18 NTM-1633; 6 placebo), and no deaths were reported. An unrelated serious adverse event was reported in a placebo subject. Adverse events in the NTM-1633 groups were generally mild and similar in frequency and severity to the placebo group, and no safety signal was identified. NTM-1633 has a favorable PK profile with a half-life >10 days for the 0.330 mg/kg dose and an approximately linear relationship with respect to maximum concentration and area under the concentration-time curve (AUC0→t). NTM-1633 also demonstrated low immunogenicity. NTM-1633 is well tolerated at the administered doses. The favorable safety, PK, and immunogenicity profile supports further development as a treatment for BoNT/E intoxication and postexposure prophylaxis.

Safety, Tolerability, and Pharmacokinetics of NTM-1632, a Novel Mixture of Three Monoclonal Antibodies against Botulinum Toxin B.

Botulism is a rare, life-threatening paralytic disease caused by Clostridium botulinum neurotoxin (BoNT). Available treatments, including an equine antitoxin and human immune globulin, are given postexposure and challenging to produce and administer. NTM-1632 is an equimolar mixture of 3 human IgG monoclonal antibodies, B1, B2, and B3, targeting BoNT serotype B (BoNT/B). This first-in-human study assessed the safety, tolerability, pharmacokinetics (PK), and immunogenicity of NTM-1632. This double-blind, single-center, placebo-controlled dose escalation study randomized 3 cohorts of healthy volunteers to receive a single intravenous dose of NTM-1632 (0.033, 0.165, or 0.330 mg/kg) or saline placebo. Safety monitoring included physical examinations, clinical laboratory studies, and vital signs. Blood sampling was performed at prespecified time points for PK and immunogenicity analyses. Twenty-four subjects received study product (18 NTM-1632; 6 placebo), and no deaths or serious adverse events were reported. Adverse events in the NTM-1632 groups were generally mild and similar in frequency and severity to the placebo group, and no safety signal was identified. NTM-1632 has a favorable PK profile with a half-life of >20 days for the 0.330-mg/kg dose and an approximately linear relationship with respect to maximum concentration and area under the concentration-time curve (AUC0→t). NTM-1632 demonstrated low immunogenicity with only a few treatment-emergent antidrug antibody responses in the low and middle dosing groups and none at the highest dose. NTM-1632 is well tolerated at the administered doses. The favorable safety, PK, and immunogenicity profile of NTM-1632 supports further clinical development as a treatment for BoNT/B intoxication and postexposure prophylaxis. (This study has been registered at ClinicalTrials.gov under identifier NCT02779140.).

Enhancing Nut Quality Parameters and Sensory Profiles in Three Almond Cultivars by Different Irrigation Regimes.

The climate change is already affecting many agricultural systems and human environments, and the implementation of adaptation strategies, especially those related to irrigated agriculture in semiarid regions, is urgent. In this regard, deep knowledge about the effects that irrigation has on the food quality parameters will allow us to estimate the potential benefits of deficit irrigation (DI) strategies. This work presents the effects on the quality parameters of three almond cultivars (Marta, Guara, and Lauranne) subjected to three irrigation doses: (i) full-irrigated treatment (FI) at 100% crop evapotranspiration (ETC), (ii) an overirrigated treatment at 150% ETC (150% ETC), and (iii) regulated deficit irrigation (RDI65) treatment, in which irrigation was done as in FI, expect during the kernel-filling period when this treatment received 65% ETC. According to experimental findings, the cultivar most sensitive to water stress was Marta, having the most significant improvements for RDI65. In general, the effects of the irrigation dose on the morphological and physicochemical parameters were not huge but some improvements were observed in key parameters such as the color and contents of specific sugars, organic acids, and unsaturated fatty acids. Thus, it can be concluded that the irrigation dose did not drastically affect the fruit almond quality, although it is possible to improve several key parameters when a moderate RDI strategy is applied.

Angiosarcoma cutáneo: estudio clínico-patológico de 16 casos / Cutaneous Angiosarcoma: Clinical and Pathology Study of 16 Cases

Introducción y objetivos: El angiosarcoma primario cutáneo es uno de los tumores más agresivos y de peor pronóstico de la piel. Su clínica inicialmente indolente justifica frecuentes diagnósticos tardíos, lo que sumado a su carácter muchas veces multifocal y a su mala delimitación suele dificultar la cirugía. Debido a su baja frecuencia existen pocas series largas de casos tratados en un mismo centro. Revisamos las características clínico-patológicas de los angiosarcomas cutáneos tratados en nuestro centro en búsqueda de factores pronósticos, así como de posibles rasgos que faciliten un diagnóstico precoz. Material y métodos: Se realizó un estudio observacional retrospectivo de todos los pacientes diagnosticados de angiosarcoma cutáneo atendidos en nuestro hospital entre enero de 2000 y diciembre de 2015. Se recogieron 16 parámetros clínicos incluidos —entre otros— edad, sexo, tipo de angiosarcoma, localización, tamaño, tiempo de evolución y además 8 parámetros histopatológicos. Resultados: Se recogieron 16 pacientes con angiosarcoma cutáneo —11 mujeres y 5 varones—, la media de edad fue de 67 años y la mediana de 71 años. La localización más frecuente fue el tronco con 10 casos, seguida de la cabeza y el cuello con 5 casos. La media del tamaño tumoral fue de 10cm y la mediana de 6,5cm. Se realizó escisión quirúrgica del tumor a 14 pacientes. Tras una media de seguimiento de 42,5 meses, 6 de los 16 pacientes seguían vivos al finalizar el estudio. Conclusiones: La supervivencia de los pacientes con angiosarcoma cutáneo viene determinada principalmente por el tamaño tumoral y la edad. Otros rasgos asociados a peor pronóstico en nuestros pacientes fueron la infiltración a planos más profundos (músculo), un patrón histológico predominantemente sólido y un mayor número de mitosis (AU)

Introduction and objectives: Primary cutaneous angiosarcoma is one of the most aggressive skin tumors and carries a very poor prognosis. Its initially indolent clinical presentation explains the frequently late diagnosis that, together with its typically multifocal pattern and poor delimitation, often makes surgery difficult. The low incidence of primary cutaneous angiosarcoma means that few large single-center series have been published. We review the clinical and pathologic characteristics of cutaneous angiosarcomas treated in our hospital, looking for prognostic factors and for possible diagnostic traits that could facilitate early diagnosis. Material and methods: This was a retrospective observational study including all patients diagnosed with cutaneous angiosarcoma in Instituto Valenciano de Oncología in Valencia, Spain between January 2000 and December 2015. We recorded 16 clinical parameters, including age, sex, type of angiosarcoma, site, size, and time since diagnosis, and 8 histopathologic parameters. Results: We identified 16 patients (11 women and 5 men) with cutaneous angiosarcoma. Their mean age was 67 years (median, 71 years). The most common site was the trunk (10 cases), followed by the head and neck (5 cases). The mean size of the tumor was 10cm (median, 6.5cm). Fourteen patients underwent surgical excision. Six of the 16 patients were alive at the end of the study, after a mean follow-up period of 42.5 months. Conclusions: The major determinants of survival among patients with cutaneous angiosarcoma are tumor size and patient age. Other characteristics associated with a poor prognosis were infiltration of deep planes (muscle), a predominantly solid histologic pattern, and a larger number of mitoses (AU)

Cutaneous Angiosarcoma: Clinical and Pathology Study of 16 Cases. / Angiosarcoma cutáneo: estudio clínico-patológico de 16 casos.

INTRODUCTION AND OBJECTIVES: Primary cutaneous angiosarcoma is one of the most aggressive skin tumors and carries a very poor prognosis. Its initially indolent clinical presentation explains the frequently late diagnosis that, together with its typically multifocal pattern and poor delimitation, often makes surgery difficult. The low incidence of primary cutaneous angiosarcoma means that few large single-center series have been published. We review the clinical and pathologic characteristics of cutaneous angiosarcomas treated in our hospital, looking for prognostic factors and for possible diagnostic traits that could facilitate early diagnosis. MATERIAL AND METHODS: This was a retrospective observational study including all patients diagnosed with cutaneous angiosarcoma in Instituto Valenciano de Oncología in Valencia, Spain between January 2000 and December 2015. We recorded 16 clinical parameters, including age, sex, type of angiosarcoma, site, size, and time since diagnosis, and 8 histopathologic parameters. RESULTS: We identified 16 patients (11 women and 5 men) with cutaneous angiosarcoma. Their mean age was 67 years (median, 71 years). The most common site was the trunk (10 cases), followed by the head and neck (5 cases). The mean size of the tumor was 10cm (median, 6.5cm). Fourteen patients underwent surgical excision. Six of the 16 patients were alive at the end of the study, after a mean follow-up period of 42.5 months. CONCLUSIONS: The major determinants of survival among patients with cutaneous angiosarcoma are tumor size and patient age. Other characteristics associated with a poor prognosis were infiltration of deep planes (muscle), a predominantly solid histologic pattern, and a larger number of mitoses.

Effect of chitosan edible films added with Thymus moroderi and Thymus piperella essential oil on shelf-life of cooked cured ham.

The aim of this work was to develop chitosan edible films added with essential oils obtained from two Thymus species, Thymus moroderi (TMEO) and Thymus piperella (TPEO) to determine their application for enhancing safety (antioxidant and antibacterial properties) and shelf-life of cooked cured ham (CCH) stored at 4 °C during 21 days. Addition of TMEO and TPEO into chitosan films decreased the aerobic mesophilic bacteria (AMB) and lactic acid bacteria (LAB) counts in coated cooked cured ham samples as compared with uncoated samples. Both AMB and LAB showed the lowest counts in CCH samples coated with chitosan films added with TPEO at 2 %. In regard to lipid oxidation, the CCH samples coated with chitosan films added with TMEO or TPEO had lower degrees of lipid oxidation than uncoated control samples. Chitosan films added with TPEO at 2 % showed the lowest values. The addition of TPEO or TMEO in chitosan films used as coated in CCH improved their shelf life.

Tomato and tomato byproducts. Human health benefits of lycopene and its application to meat products: a review.

During recent decades, the food industry, consumers, and regulatory authorities have developed a significant interest in functional foods because of their potential benefits for human health over and above their basic nutritional value. Tomato is the second most important vegetable crop in the world. The amount of the related wastes is estimated at up to 50,000 tons per year, representing a serious disposal problem with a consequent negative impact on the environment. Tomato byproducts contain a great variety of biologically active substances, principally lycopene, which have been demonstrated by in vitro and in vivo studies to possess antioxidant, hypolipidemic, and anticarcinogenic activities. The aim of this review is to present an overview of the functional and physiological properties of the principal bioactive compound present in tomato and tomato byproducts, lycopene, its addition to meat, and meat products.

Food ingredients as anti-obesity agents: a review.

Overweight and obesity have a major impact on global health; their prevalence has rapidly increased in all industrialized countries in the past few decades and diabetes and hypertension are their direct consequences. Pharmacotherapy provides reinforcement for obesity treatment, but should be an adjunctive support to diet, exercise, and lifestyle modification. At present, only orlistat and sibutramine have been approved by the US Food and Drug Administration for long-term use, but sibutramine was withdrawn for sale by the European Medicines Agency. The development of functional foods for the prevention and/or treatment of obesity suppose an opportunity for the food market and involve the knowledge of the mechanisms of appetite and energy expenditure as well as the metabolic sensation of satiety. Strategies for weight control management affect gut hormones as potential targets for the appetite metabolic regulation, stimulation of energy expenditure (thermogenesis), and modifications in the metabolic activity of the gut microbiota. Functional foods for obesity may also include bioactive fatty acids, phenolic compounds, soybean, plant sterols, dietary calcium, and dietary fiber. This review intends to offer an overview of the present situation of the anti-obesity agents currently used in dietary therapy as well as some functional food ingredients with potentially anti-obesity effects.

Analysis of the influence of variation factors on electrical conductivity of milk in Murciano-Granadina goats.

The aim of this study was to obtain further knowledge on electrical conductivity (EC) of milk as a tool for detecting mastitis in goats. The effect of farm, parity, stage of lactation, and health status of the glands on EC, and the somatic cell count (SCC) of milk was analyzed. Additionally, relationships between EC and chemical composition and SCC were studied. Finally, characteristics of EC and SCC (sensitivity and specificity) as diagnostic tests used to detect mastitis were studied. One hundred and five Murciano-Granadina goats were enrolled in the study. Milk samples (by gland) were collected monthly for 7 mo on 3 farms in the southeastern Spain. To establish the health status, milk samples were aseptically collected before milking by gland. Foremilk (by gland) was collected to analyze EC, SCC, and chemical composition. Glands were classified according to the health status as free of mastitis, bacterial mastitis, or unspecific mastitis. The effects of farm, parity, and stage of lactation, as well as the interactions between health status and parity, parity and stage of lactation, and health status and stage of lactation were associated with EC. Changes in the milk's chemical composition (particularly of chloride ions) explained most of the variance in EC (R(2)=0.91). The strongest association between EC and SCC was found at SCC >2×10(6) cells/mL (r=0.42). The use of a single EC threshold for all animals and farms for detecting mastitis led to limited results for mastitis detection, which, in any case, favors negative predictive values over positive predictive values. This study revealed that factors, other than the health status, affecting EC hamper the use of an EC threshold for mastitis detection with sufficient specificity on all animals. Any detection system based on EC of milk should consider these factors, as well as specific variations for each of the animals.

Effect of the molecular weight and concentration of chitosan in pork model burgers.

Chitosan of high and low molecular weights was added at 0%, 0.25%, 0.5% and 1% concentrations to a burger model system. Burgers were evaluated by physicochemical analysis, cooking characteristic and storage stability. The antioxidant activity of chitosan was studied in vitro. The addition of chitosan influenced pH and color properties, in molecular weight and concentration dependent ways. Cooking properties were significantly affected by the chitosan. High molecular weight chitosan improved all cooking characteristics compared with control samples. Low molecular weight chitosan increased the shelf life of burgers, enhanced the red color and reduced total viable counts, compared with control and high molecular weight chitosan samples. The antioxidant activity of chitosan was dependent on molecular weight and concentration. The results indicate that high molecular weight chitosan (HMWC) improves all cooking characteristics and antioxidant activity while low molecular weight chitosan extends the red color and reduces total viable counts.

Effect of tiger nut fibre on quality characteristics of pork burger.

Horchata is a refreshing beverage obtained from tiger nut tubers that yields high amount of by-products. These by-products have a high content of fibre that allows its application in the development of dietary fibre rich foods. The utilization of increasing levels (0%-control, 5%, 10% and 15%) of tiger nut fibre (TNF), in the formulation of pork burgers was evaluated. This evaluation was based on: chemical composition, physicochemical, cooking characteristics and sensory properties of burgers. Pork burgers elaborated with TNF had higher nutritional value (higher fibre content) and better cooking characteristics (higher cooking yield, fat retention and moisture retention) than control burgers. Some of the negative changes in colour (a* decrease and b* increase) and texture (chewiness and springiness increase) parameters due to TNF addition observed in raw burgers were masked by the stronger modifications due to the cooking process. Burgers with TNF were perceived as less greasy, less juicy, more grainy and with less meaty flavour than controls; although this perception did not reduce the overall acceptability of burgers. Overall acceptability scores were slightly lower in burgers with 15% TNF, although no significant differences were detected with the scores of control, 5% and 10% TNF burgers. TNF addition to burgers is a promising and convenient application as dietary fibre of burgers was significantly increased without changes in sensory acceptance.

Citrus co-products as technological strategy to reduce residual nitrite content in meat products.

Sodium or potassium nitrite is widely used as a curing agent in cured meat products because it inhibits outgrowth and neurotoxin formation by Clostridium botulinum, delays the development of oxidative rancidity, develops the characteristic flavor of cured meats, and reacts with myoglobin and stabilizes the red meat color. As soon as nitrite is added in the meat formulation, it starts to disappear and the nitrite that has not reacted with myoglobin and it is available corresponds to residual nitrite level. Health concerns relating to the use of nitrates and nitrites in cured meats (cooked and dry cured) trend toward decreased usage to alleviate the potential risk to the consumers from formation of carcinogenic compounds. Recently, some new ingredients principally agro-industrial co-products in general and those from the citrus industry in particular (albedo [with different treatments], dietetic fiber obtained from the whole co-product, and washing water used in the process to obtain the dietetic fiber) are seen as good sources of bio-compounds that may help to reduce the residual nitrite level in meat products. From these co-products, citrus fiber shows the highest potential to reduce the residual nitrite level, followed by the albedo and finally the washing water. The aim of this article is to describe the latest advances concerning the use of citrus co-products in meat products as a potential ingredient to reduce the nitrite level.

Seasonal changes in the somatic indices of the freshwater silverside, Odontesthes bonariensis (Teleostei, Atheriniformes) from a Neotropical shallow lake (Argentina).

The study object was an Odontesthes bonariensis (Valenciennes, 1835) population of a characteristically shallow lake from the pampasic region. Over one year, zooplankton and fish samples were collected monthly. As a function of time and gender, several indices were investigated (relative weight, mesentery fat index, gonadosomatic index, hepatosomatic index and somatic index) and were related to zooplanktonic community dynamics, the main energy food source for this species. The results indicate that the seasonal information contained in the weight compartments is most important in mesentery fat, gonads and liver. The zooplankton availability modulates reserves (fat) behaviour and physiologic activity (liver), determining spawn intensity. Thus, in spring spawns, with higher zooplankton availability, mature individuals of the population, males and females, transfer energy from the food to the gonads. In autumn spawns, they use the fat reserves for gonad ripening.

Seasonal changes in the somatic indices of the freshwater silverside, Odontesthes bonariensis (Teleostei, Atheriniformes) from a Neotropical shallow lake (Argentina) / Mudanças sazonais nos índices somáticos do Odontesthes bonariensis (Teleostei, Atheriniformes) em uma lagoa da região Neotropical (Argentina)

The study object was an Odontesthes bonariensis (Valenciennes, 1835) population of a characteristically shallow lake from the pampasic region. Over one year, zooplankton and fish samples were collected monthly. As a function of time and gender, several indices were investigated (relative weight, mesentery fat index, gonadosomatic index, hepatosomatic index and somatic index) and were related to zooplanktonic community dynamics, the main energy food source for this species. The results indicate that the seasonal information contained in the weight compartments is most important in mesentery fat, gonads and liver. The zooplankton availability modulates reserves (fat) behaviour and physiologic activity (liver), determining spawn intensity. Thus, in spring spawns, with higher zooplankton availability, mature individuals of the population, males and females, transfer energy from the food to the gonads. In autumn spawns, they use the fat reserves for gonad ripening.

O objeto do estudo foi a população Odontesthes bonariensis (Valenciennes, 1835) de uma lagoa característica da região dos pampas argentinos. Durante um ano, recolheram-se mostras mensais da comunidade zooplanctônica e da população de peixe-rei. Pesquisaram-se vários índices (peso relativo e os índices de gordura mesentérica, gônado-somático, hepato-somático e somático) em função do tempo e do sexo, relacionando-os com a dinâmica de comunidade de zooplâncton, a principal fonte de energia para esta espécie. Os resultados indicam que a informação sazonal contida nos compartimentos de peso é muito importante na gordura mesentérica, nas gônadas e no fígado. A disponibilidade do zooplâncton modula as reservas (gordura), o comportamento e a atividade fisiológica (fígado), determinando a intensidade da desova. Assim, na desova de primavera, com disponibilidade mais elevada do zooplâncton, a maioria dos indivíduos maduros da população, machos e fêmeas, transferem energia do alimento às gônadas. No outono os peixes usariam principalmente as reservas de gordura para a maduração gonadal.

Metástasis endotraqueales de carcinoma colorrectal / No disponible

La existencia de metástasis endotraqueales (ME) de carcinomas de origen no pulmonar es rara. Las manifestaciones clínicas más comunes son hemoptisis, tos y disnea, aunque no es raro encontrarlas como hallazgo casual en el curso de una broncoscopia. Las neoplasias que con mayor frecuencia se asocian a estas lesiones metastásicas son las derivadas de mama, colon y riñón. Su hallazgo supone un estado avanzado de la enfermedad, aunque la supervivencia está en función del tipo de tumor primario, la existencia de lesiones concomitantes y las características del paciente. Por lo tanto el tratamiento debe individualizarse. En el caso de las ME de carcinoma colorrectal (CCR) recomendamos la realización de una broncoscopia preopcratoria pues es posible encontrar lesiones en el árbol traqueobronquial que influyan en el pronóstico y tratamiento de la enfermedad (AU)

Existence of endotracheal metastases (EM) of non-pulmonary origin cancer is rare. The most common clinical manifestations are hemoptysis, cough and dyspnea, although it is not rare to find it as a casual finding during a bronchoscope examination. The neoplasms that are most frequently associated to these lesions are those derived from the breast, colon and kidney. When they are found, it means that there is an advanced stage of the disease, although survival is based on the type of primary tumor, existence of common commitment lesions and the characteristics of the patient. Thus, the treatment should be individualized. In the case of colorectal carcinoma (CRC) EM, we recommend performing a pre-operative bronchoscopy since lesions that influence the prognoses and treatment of the disease may be found in the trachea and bronchial tree (AU)

Endotracheal metastases from colon adenocarcinoma

Endotracheal metastases (ETM) from non-lung cancer are seldom seen. Their main clinical symptoms are cough, haemoptysis and dyspnoea, although occasionally an incidental finding is made during a bronchoscopy. Breast, colon and kidney adenocarcinoma might be associated with ETM, lung cancer being the most frequent cause. Its finding is associated with advanced disease but survival will depend on the primary origin, patient status and comorbidity. Therefore, treatment should be individual for each patient. In our centre we recommend pre-surgery bronchoscopy to exclude metastatic endotracheal lesions in patients with metastatic colon adenocarcinoma disease, as this might affect the final outcome and therefore management of the disease (AU)

No disponible

Effect of packaging conditions on shelf-life of ostrich steaks.

This study was conducted to establish the shelf-life of ostrich steaks stored in four different packaging types: (i) air exposure, (ii) vacuum, and two different modified atmospheres packages (iii) MAP: 80% CO(2)+20% N(2,) and (iv) MAP+CO: 30% CO(2)+69.8% argon+0.2% CO. Shelf-life evaluation was based on colour, lipid and hemopigments oxidation, microbial counts and sensory assessment of odour and colour. Samples stored under air exposure showed the highest lipid and hemopigments oxidation rate. Based on aerobic bacteria counts, the shelf life of ostrich steaks stored under aerobic conditions would be 8 d at most, whereas under vacuum, MAP or MAP+CO it would be 12 d. The presence of CO extends the shelf life of ostrich steaks by stabilisation of red colour measured by instrumental and sensory techniques, and maintenance of fresh meat odour by slowing down off-odour perception.

Physico-chemical and microbiological profiles of "salchichón" (Spanish dry-fermented sausage) enriched with orange fiber.

Spanish dry-fermented sausages with three concentrations (0, 1 and 2%) of orange fiber (juice industry by-product) were prepared and studied. Fermentation and dry-curing processes were followed by physico-chemical (pH and water activity), chemical (moisture, lactic acid and residual nitrite level) and microbiological (aerobic mesophilic bacteria, lactic acid bacteria, Enterobacteriaceae, Micrococcaceae and molds and yeasts counts) analysis. Sensory analyses were conducted on the finished products. Only residual nitrite level and counts of micrococcus were affected by fiber addition during fermentation. pH, water activity, residual nitrite level and counts of Micrococcaceae were affected by fiber addition during dry-curing. Orange fiber decreases residual nitrite levels and favours micrococcus growth. Both effects have a positive impact on sausage safety and quality. The reduction in residual nitrite level decreases the risk of nitrosamine formation. For all sensorial attributes evaluated sausages containing 1% fiber showed similar scores to controls.

Quality characteristics of ostrich (Struthio camelus) burgers.

Quality characteristics and storage stability of three types of burgers prepared with ostrich meat (alone or mixed with pork or beef meat) were evaluated. Burger evaluation was based on chemical, microbiological, textural, colour, sensory and oxidation characteristics. All of the assayed formulas showed acceptable general quality scores in the sensory evaluation, but the burgers formulated with 100% ostrich meat or mixing ostrich and beef meat had the highest scores. Only TBA values and redness were influenced by storage time. Burgers formulated with ostrich and pork meat had a faster oxidation rate and became more oxidized than the others. Microbial counts indicated that, at the end of the refrigerated storage (9days), all of the preparations were spoiled.

[Randomised clinical trial of an intensive intervention into life-styles of patients with hyperfibrinogenaemia in primary prevention of cardiovascular pathology in primary health care]. / Ensayo clínico aleatorizado de una intervención intensiva sobre los estilos de vida de pacientes con hiperfibrinogenemia en prevención primaria de las enfermedades cardiovasculares en el ámbito de la atención primaria de salud.

OBJECTIVES: To study the effect of an intensive programme to modify life-style on levels of plasma fibrinogen in patients without cardiovascular pathology, with high fibrinogen and normal cholesterol levels. To analyse whether the effect on fibrinogen is independent, or otherwise, of the effect on lipids. DESIGN: Randomised clinical trial with a control. SETTING: 11 health districts in L'Hospitalet de Llobregat and Barcelona. PARTICIPANTS: 436 patients will be included, 218 individuals between 35 and 75 years old in each group, and without cardiovascular pathology (ischaemic cardiopathy, cerebral vascular accident or peripheral arteriopathy), with hyperfibrinogenaemia (fibrinogen > 300 mg/dL) and with plasma control < 250 mg/dL. INTERVENTIONS: One group of patients will receive an intensive intervention (in frequency and intensity of counselling and treatment) for life-style changes, i.e. stopping smoking, low-calorie diet in case of overweight or obesity, and physical exercise. The follow-up of the intervention group will be every 2 months. The control group will follow customary treatments. MEASUREMENTS: Levels of plasma fibrinogen. In addition, other relevant events will be recorded over a 2-year monitoring period: modification of risk factors, changes in quality of life, cardiovascular events or death. DISCUSSION: The introduction of an intensive primary prevention intervention (life-style changes) in patients with hyperfibrinogenaemia could be a more effective measure than the habitual intervention for reducing plasma fibrinogen figures. In addition, these measures could be translated into a reduction of cardiovascular risk and an improvement in the patient s quality of life.