Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City

Celiac Disease Clinical Trial

Official title:

Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312349
• Other study ID #: 1770
• Status: Completed
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: August 2019
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Ciudad Autonoma de Buenos Aires

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires	Universidad Isalud

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Knowledge about Celiac Disease	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	At baseline
Secondary	Appropriate preparation, delivery and storage of Gluten Free dishes	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	At baseline