Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
1 other identifier
observational
112
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 3, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedAugust 13, 2019
August 1, 2019
1.3 years
December 3, 2014
August 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gluten Free elaborated food
Percentage of any available elaborated food free of gluten in its preparation an components for each restaurant evaluated
At baseline
Secondary Outcomes (2)
Knowledge about Celiac Disease
At baseline
Appropriate preparation, delivery and storage of Gluten Free dishes
At baseline
Eligibility Criteria
It will generate a stratified random sample of 15% of businesses (restaurants, bars, pizzerias and fast food outlets) located in the three selected districts. To be used to sample a sampling frame of the selected districts conducted by the same research group (NCT01388972).
You may qualify if:
- \- Restaurants, bars, pizzerias and fast food outlets, located in the three selected districts.
You may not qualify if:
- Refusal by the owner or manager of local participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Italiano de Buenos Aireslead
- Universidad Isaludcollaborator
Study Sites (1)
Hospital Italiano de Buenos Aires
Buenos Aires, C1181ACH, Argentina
Related Publications (1)
Garipe LY, Bravo B, Fernandez M, Garcia M, Petrosini A, Soriano MM, Perman GP, Giunta DH. Evaluacion de la oferta de alimentos libres de gluten en locales de comida elaborada en la Ciudad Autonoma de Buenos Aires. Acta Gastroenterol Latinoam. 2015 Sep;45(3):190-7. Spanish.
PMID: 28590109DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
December 3, 2014
First Posted
December 9, 2014
Study Start
September 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
August 13, 2019
Record last verified: 2019-08