- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02312349
Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
Celiac disease (CD) is a chronic autoimmune disorder in genetically susceptible individuals characterized by inflammation of the small intestine due to gluten intolerance. This protein is found in cereals such as wheat, barley and rye. In Argentina, oats are also considered a toxic grain since are as highly contaminated as the previous three. For this reason, the acronym TACC (Trigo, avena, cebada y centono: wheat, oats, barley and centono) is used for their identification. An effective treatment for celiac disease consists in a gluten-free diet (GFD). For most patients, a gluten-free intake results in a symptomatic and pathological complete remission and decreases the risk of complications.
The overall prevalence of CD is around 1% in several Western countries. An Argentinian study shows a 1.167 prevalence of CD in studied patients, being doubled for women than men. Another study in a closed population of the Health Plan of Hospital Italiano de Bs As estimated a prevalence of 0.22 CD diagnosis. In developed countries, for each diagnosed case there is an average of 5-10 cases that have not been diagnosed yet.
CD patients and their families should be properly informed about GFD, since there are many factors, voluntary and involuntary, which can affect the treatment. Even though a strict diet is imperative, food handling awareness is equally important in order to prevent cross-contamination and gluten intake hidden in certain products.
In recent years, several countries have shown an increasing interest in improving the supply of gluten-free foods in supermarkets, food factories and restaurants. In turn, a British study shows that chefs have less awareness about celiac disease than the overall population. Another Canadian study, which assessed the quality of life of people with CD, revealed that 80% of them avoid eating in restaurants for fear of contamination, causing a decrease in their social life.
In Argentina, there are associations that generate lists of marks and gluten-free products allowing safe intake of processed foods, however, it is unknown the food supply suitable for consumption for people with CD as well as the staff's knowledge in gluten-free food preparation in restaurants, pubs, pizzerias and fast food places. U.S. has quality assurance systems that certify good manufacturing practices and GFD handling in restaurants and selling local foods, although its application is not mandatory. In our country, there is no such certification, so food safety on restaurants can not be guaranteed.
Eating behaviors are influenced by the reality in which people live, including food availability indoors and outdoors. The current lifestyle leads more and more people to make meals away from home, so that the variety and quality of food sold in restaurants and other stores conditions the consumption. Thus, the availability of "safe" foods in places where people with CD carried some of their meals, help improve adherence to the GFD.
The aim of this study is to investigate gluten-free products' supply in elaborated food stores in Buenos Aires City and to discover the level of information possessed by manufacturers in the production of food.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
- Hospital Italiano de Buenos Aires
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Restaurants, bars, pizzerias and fast food outlets, located in the three selected districts.
Exclusion Criteria:
-Refusal by the owner or manager of local participation in the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Ecológico ou Comunitário
- Perspectivas de Tempo: Transversal
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Gluten Free elaborated food
Prazo: At baseline
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Percentage of any available elaborated food free of gluten in its preparation an components for each restaurant evaluated
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At baseline
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Knowledge about Celiac Disease
Prazo: At baseline
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Direct structure questionnaire about specific items related to knowledge about celiac disease directed to every person involved in storage, preparation or delivery of elaborated food
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At baseline
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Appropriate preparation, delivery and storage of Gluten Free dishes
Prazo: At baseline
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Direct evaluation by inspection of the complete process of storage, preparation or delivery of elaborated food in each restaurant to detect potential sources of gluten contamination
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At baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1770
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