Celiac DiseaseNCT02312349
Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
An observational study of Celiac Disease, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Celiac Disease
- How many people
- 112 participants
- Where
- 1 siteArgentina
- Study dates
- Sep 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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).
Who may be able to join
- Restaurants, bars, pizzerias and fast food outlets, located in the three selected districts.
Who cannot join
- -Refusal by the owner or manager of local participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, Gluten free elaborated food
- Medical subject headings
- Celiac Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Gluten Free elaborated food
Percentage of any available elaborated food free of gluten in its preparation an components for each restaurant evaluated
Measured: At baseline
Secondary outcomes (2)
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
Measured: At baseline
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Isalud
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312349
- Sponsor's protocol ID
- 1770
- Status last verified
- Aug 2019
- First submitted
- 3 Dec 2014
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28590109
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gluten-Free Availability in Elaborated Food Stores in Three Neighbourhoods of Buenos Aires City
- ClinicalTrials.gov ID
- NCT02312349
- Acronym / sponsor ID
- 1770
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, Gluten free elaborated food
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Universidad Isalud
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- Restaurants, bars, pizzerias and fast food outlets, located in the three selected districts.
Key exclusion criteria (1 listed)
- -Refusal by the owner or manager of local participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gluten Free elaborated food
Time frame: At baseline
Percentage of any available elaborated food free of gluten in its preparation an components for each restaurant evaluated
2 secondary outcomes
Knowledge about Celiac Disease
Time frame: At baseline
Appropriate preparation, delivery and storage of Gluten Free dishes
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 28590109Garipe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gluten Free elaborated food (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.